[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable-hepatocellular-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable-hepatocellular-carcinoma":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,41,71,194,221,244,270,291,318,341,366,387,415,437,469,493,513,539,562,587,606,627,649,673,693],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100645182","first-line-nivolumab-plus-ipilimumab-in-unresectable-hepatocellular-carcinoma-j-promise-100645182",false,"NCT07679061","First-Line Nivolumab Plus Ipilimumab in Unresectable Hepatocellular Carcinoma (J-PROMISE)","Prospective Observational Study of First-Line Nivolumab Plus Ipilimumab in Patients With Unresectable Hepatocellular Carcinoma in Japan (J-PROMISE)","Inclusion Criteria:\n\n* Participants aged ≥ 18 years at the time of consent\n* Participants with unresectable hepatocellular carcinoma (uHCC), defined as disease not eligible for curative surgical and\u002For locoregional therapies, or progressive disease after surgical and\u002For locoregional therapies\n* Child-Pugh class A (total score 5-6)\n* Participants who have not received prior systemic drug therapy for uHCC\n\n  * Participants who relapsed more than 6 months after completion of postoperative adjuvant therapy are eligible\n  * Participants who received lenvatinib in combination with transarterial chemoembolization (TACE) are eligible if the treating physician determined they were eligible for TACE; participants are excluded if TACE eligibility at the time of lenvatinib initiation is unclear\n* Participants scheduled to initiate nivolumab plus ipilimumab combination therapy between March 1, 2026 and February 28, 2027\n\n  * Nivolumab plus ipilimumab combination therapy is defined as nivolumab 80 mg and ipilimumab 3 mg\u002Fkg administered intravenously every 3 weeks for 4 cycles, followed by nivolumab monotherapy at 240 mg every 2 weeks or 480 mg every 4 weeks\n* Participants who provide written informed consent prior to initiation of nivolumab plus ipilimumab therapy\n\nExclusion Criteria:\n\n* Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma\n* Prior liver transplant\n* ECOG performance status ≥ 3\n* Uncontrolled comorbidities despite treatment\n* Other advanced cancers requiring systemic therapy\n* Prior immuno-oncology treatment\n* Participation in interventional clinical trials at enrollment\n* Deemed unsuitable by investigator","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","This study looks at how a combination of two medicines, nivolumab and ipilimumab, is used to treat people with advanced liver cancer that cannot be removed by surgery. The study will follow adults receiving this treatment in routine medical care in Japan to understand how safe it is, how well it works, and how it is used in standard clinical practice.",[25],"Unresectable Hepatocellular Carcinoma",[27],"Hepatocellular carcinoma; HCC; nivolumab; ipilimumab","RECRUITING","2026-06-25",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":32},"2026-03-05",{"date":36,"type":21},"2028-02-29",{"name":38,"class":39},"Bristol-Myers Squibb","INDUSTRY",2,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100601418","yttrium-90-radiation-segmentectomy-for-hepatocellular-carcinoma-100601418","NCT07110233","Yttrium-90 Radiation Segmentectomy for Hepatocellular Carcinoma","Prospective Phase 2 Trial of Yttrium-90 Radiation Segmentectomy for Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Participants must have histologically or imaging-confirmed confirmed HCC.\n2. Group 1: Solitary tumor measuring 2-5 cm Or Group 2: 2-3 tumors each ≤ 3 cm in diameter.\n3. No prior therapy to target tumor(s).\n4. Not a candidate for surgical resection or thermal ablation after multidisciplinary assessment.\n5. Age ≥22 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status = 0 or 1.\n7. Demonstrated adequate organ function as defined below:\n\n   1. Total bilirubin ≤3.0 mg\u002FdL, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits.\n   2. aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) ≤5 X institutional upper limit of normal.\n   3. alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase (SGPT) ≤5 X institutional upper limit of normal.\n   4. Creatinine Glomerular filtration rate (GFR) \\> 30 ml\u002Fmin.\n8. Child-Pugh score ≤ B7\n9. Albumin-bilirubin (ALBI) score 1-2\n10. Participants who have received systemic therapy for HCC will be excluded from the trial.\n11. Ability to understand a written informed consent document, and the willingness to sign it.\n12. Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n13. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nExclusion Criteria:\n\n1. Macrovascular tumor invasion or infiltrative appearance of hepatocellular carcinoma.\n2. History of severe allergy to iodinated contrast agents despite appropriate premedication.\n3. Is currently receiving any other anti-cancer agents and any previous therapy with a device that uses Y90 as the radioisotope.\n4. Symptomatic heart failure or severe valvular insufficiency.\n5. Symptomatic pulmonary hypertension or lung disease.\n6. Symptomatic ascites.\n7. Severe uncontrolled coagulopathy International Normalized Ratio (INR) ≥ 3.0 or Platelet ≤ 20,000.\n8. Main vein thrombosis (portal vein, both bland and tumor thrombus). Note: Less than lobar portal vein thrombosis is allowable only if the thrombus is bland.\n9. Pregnant women are excluded from this study because TheraSphere emits radiation with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TheraSphere, breastfeeding should be discontinued if the mother is treated with TheraSphere.\n10. Lung-shunt fraction (LSF) resulting in anticipated lung dose of \\>30 Gray (Gy).\n11. History of sphincterotomy, biliary-enteric anastomosis, or other biliary tract instrumentation. Note: Prior cholecystectomy with or without bile duct exploration is permitted.\n12. Tumor perfused by extrahepatic collateral arteries.\n13. Prior partial hepatectomy.\n14. Psychiatric illness, other significant medical illness, or social situation which, in the investigator's opinion, would limit compliance or ability to comply with study requirements.\n15. History of or current extrahepatic cancer.\n16. Pulmonary insufficiency (defined by an arterial oxygen pressure (Pa,O2) of \\\u003C 60 mmHg, or oxygen saturation (Sa,O2) of \\\u003C 90%).","22 Years",{"count":50,"type":21},64,"INTERVENTIONAL",[53],"NA","This is a prospective, single-blinded, single-arm, open-label Phase II trial of trans-arterial radiation segmentectomy using Yttrium-90 glass microspheres (TheraSphere®) for Hepatocellular Carcinoma (HCC) participants with unresectable Barcelona clinic liver cancer (BCLC) stage A disease.",[56,25,57,58],"Hepatocellular Carcinoma","Hepatocellular Cancer","Hepatocellular Carcinoma Non-resectable","NOT_YET_RECRUITING","2026-06-23",{"date":62,"type":32},"2026-06-26",{"date":64,"type":21},"2026-10-01",{"date":66,"type":21},"2029-03-31",{"name":68,"class":69},"University of California, San Francisco","OTHER",1,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":51,"phases":82,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":70},"100459958","phase-1-personalized-neoantigen-peptide-based-vaccine-in-combination-with-pembrolizumab-for-treatment-of-advanced-solid-tumors-100459958","NCT05269381","Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors","A Phase I\u002FII Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)","PNeoVCA","Inclusion Criteria COHORT 1 and COHORT 2 are no longer enrolling.\n\nPHASE I PRE-REGISTRATION, ALL:\n\n* Willing to provide tissue specimens per protocol\n\n  * NOTE: includes fresh tissue specimen at pre-registration for complete exome and transcriptome sequencing. Patients who had tumor sequencing under certain Mayo Institutional Review Board (IRB) protocols and neoantigen has been identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration.\n* Measurable disease as defined by RECIST (version 1.1) criteria or non-measurable disease\n\n  * NOTE: Tumor lesions in previously irradiated area are not considered measurable disease\n* Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have received and progressed on at least one line of prior FDA-approved targeted therapy\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up\n* Willing to provide blood specimens for research\n* Negative pregnancy test =\\\u003C 7 days prior to pre-registration for persons of childbearing potential. If urine test cannot be confirmed negative, serum pregnancy test will be required.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one =\\\u003C 1 year prior to pre-registration\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1\n* Anticipated life expectancy \\> 6 months\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status (see specified inclusion limits for laboratory toxicity) or National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo).\n* The following lab values obtained =\\\u003C 28 days prior to pre-registration:\n\n  * Hemoglobin \\>= 9.0 g\u002FdL (Must be \\>= 7 days after most recent transfusion)\n  * Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 or \\>= 1.5 X 10\\^9\u002FL\n  * Platelet count \\>= 100,000\u002Fmm\\^3 or \\>= 100 X 10\\^9\u002FL (Must be \\>=7 days after most recent transfusion)\n  * Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) =\\\u003C 3 x ULN or =\\\u003C 5 x ULN with liver metastases\n  * Creatinine =\\\u003C 1.5 x ULN OR calculated creatinine clearance must be \\>= 50 ml\u002Fmin using Cockcroft-Gault formula\n  * International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy in which case PT or PTT must be within target range of therapy\n\nPHASE I REGISTRATION, ALL:\n\n* Successful sequencing and production of REAL-Neo vaccine\n* Measurable disease as defined by RECIST (version 1.1) criteria or non-measurable disease\n\n  * NOTE: Tumor lesions in previously irradiated area are not considered measurable disease\n* ECOG PS 0 or 1\n* Anticipated life expectancy \\> 6 months\n* The following lab values obtained =\\\u003C 14 days prior to registration:\n\n  * Hemoglobin \\>= 9.0 g\u002Fdl\n  * ANC \\>= 1500\u002Fmm\\^3\n  * Platelet count \\>= 100,000\u002Fmm\\^3\n  * Total bilirubin =\\\u003C 1.5 x ULN\n  * ALT and AST =\\\u003C 3 x ULN (=\\\u003C 5 x ULN with liver involvement)\n  * PT\u002FINR and aPTT =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy in which case INR or aPTT must be within target range of therapy\n  * Calculated creatinine clearance \\>= 50 ml\u002Fmin using Cockcroft-Gault formula\n* Provide written informed consent\n* Willing to provide blood and tissue specimens for research\n* Willing to return to enrolling institution for follow-up\n* Patients with actionable genomic abnormality including, but not limited to EGFR, ALK, MET, ROS-1, RET, NTRK, KRAS or BRAF must have also received and progressed on at least one line of prior FDA-approved targeted therapy\n* Negative pregnancy test =\\\u003C 14 days prior to registration for persons of childbearing potential only\n\n  * NOTE: If urine test cannot be confirmed negative, serum pregnancy test will be required\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one =\\\u003C 1 year prior to pre-registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicity see specified limits for inclusion) or NCI CTCAE version 5.0 Grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo)\n\nPHASE II PRE-SCREENING COHORT 3 ONLY:\n\n* ECOG PS 0 or 1\n* Histological confirmation of adenocarcinoma of the breast with estrogen receptor (ER) \\\u003C 10%, progesterone receptor (PR) \\\u003C 10%, and HER2 negative based on current American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guideline\n* Stage I-III based on 7th edition of TNM staging system from American Joint Committee on Cancer (AJCC)\n* Evidence of residual disease \\>= 1 cm after neoadjuvant pembrolizumab-based chemotherapy on imaging for patients who have not had surgery\n* Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-SCREENING COHORT 4 ONLY:\n\n* ECOG PS 0 or 1\n* Histological confirmation of lung NSCLC\n* No actionable EGFR mutations and ALK fusions\n* Stage II or stage III based on AJCC 8th\n* Tumor \\>= 2 cm on pre-surgery evaluation imaging (residual disease \\>= 2 cm after neoadjuvant therapy on pre-surgery evaluation imaging in patient who receives neoadjuvant therapy) for patients who have not had surgery. Patients with or without neoadjuvant chemotherapy or immunotherapy are allowed\n* Provide written informed consent\n* Willing to proceed with surgery and provide tissue and blood specimens for patients who have not had surgery\n* Willing to return to enrolling institution for follow-up\n\nPHASE II PRE-REGISTRATION COHORT 3 (TNBC) ONLY:\n\n* Histologically confirmed residual cancer burden 2 and 3 in surgical specimens\n\nPHASE II PRE-REGISTRATION COHORT 4 (NSCLC) ONLY:\n\n* Tumor without complete pathologic response is confirmed in pathology\n* Willing to proceed with surgery and provide tissue specimens for complete exome and transcriptome sequencing\n\n  * NOTE: Patients who had sequencing under certain Mayo IRB protocols and neoantigens identified or REAL Neo vaccine produced are allowed to proceed to pre-registration and\u002For registration\n* Negative pregnancy test ≤7 days prior to pre-registration for persons of childbearing potential only. If urine test cannot be confirmed negative, serum pregnancy test will be required.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* ECOG PS of 0 or 1\n* Anticipated life expectancy \\> 6 months\n\nPHASE II REGISTRATION:\n\n* Successful sequencing and production of REAL-Neo vaccine\n* Patients will receive \\>= 2 additional cycles of maintenance pembrolizumab\n* ECOG PS 0 or 1\n* Anticipated life expectancy \\> 6 months\n* The following lab values obtained =\\\u003C 14 days prior to registration:\n\n  * Hemoglobin \\>= 9.0 g\u002Fdl\n  * ANC \\>= 1500\u002Fmm\\^3\n  * Platelet count \\>= 100,000\u002Fmm\\^3\n  * Total bilirubin =\\\u003C 1.5 x ULN\n  * ALT and AST =\\\u003C 3 x ULN (=\\\u003C 5 x ULN with liver involvement)\n  * PT\u002FINR and aPTT =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy in which case INR or aPTT must be within target range of therapy\n  * Calculated creatinine clearance \\>= 50 ml\u002Fmin using Cockcroft-Gault formula\n* Provide written informed consent\n* Willing to provide blood specimens for research\n* Willing to return to enrolling institution for follow-up\n* Negative pregnancy test =\\\u003C 14 days prior to registration for persons of childbearing potential only. If urine test cannot be confirmed negative, serum pregnancy test will be required.\n* Willing to employ highly effective method of contraception from pre-registration through 6 months after final vaccine cycle\n* Willing to receive tetanus vaccination if subject has not had one =\\\u003C 1 year prior registration\n* Recovered from all toxicities associated with prior treatment to acceptable baseline status NCI CTCAE version 5.0 Grade of 0 or 1, except for toxicities not considered safety risk per treating investigator (e.g., alopecia or vitiligo)\n\nExclusion Criteria\n\nALL PHASES:\n\n* Any of the following because study involves investigational agent whose genotoxic, mutagenic and teratogenic effects on developing fetus and newborn are unknown:\n\n  * Pregnant person\n  * Nursing person unwilling to stop breast feeding\n  * Person of childbearing potential unwilling to employ adequate contraception from registration through 6 months after final vaccine cycle\n* Co-morbid systemic illnesses or other severe concurrent disease which, in judgment of investigator, would make patient inappropriate for entry into this study or interfere significantly with proper assessment of safety and toxicity of prescribed regimens\n* History of myocardial infarction =\\\u003C 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.\n* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy\n\nPHASE I PRE-REGISTRATION:\n\n* Acute, reversible effect(s) of prior therapy not recovered to baseline regardless of interval since last treatment\n* Uncontrolled illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Congestive heart failure with New York Heart Association (NYHA) class III or IV moderate to severe objective evidence of cardiovascular disease\n  * Stroke =\\\u003C 3 months prior to pre-registration\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered treatment for primary neoplasm, except pembrolizumab\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy =\\\u003C 3 years prior to pre-registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* History of active autoimmune disease (AD) that required systemic treatment in =\\\u003C 30 days (i.e., use of disease modifying agents, corticosteroids \\> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded PHASE I REGISTRATION\n* Any of the following prior therapies:\n\n  * Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) =\\\u003C 3 weeks prior to registration\n  * Radiation =\\\u003C 2 weeks prior to registration\n  * Major Surgery =\\\u003C 4 weeks prior to registration\n  * Received live vaccine =\\\u003C 30 days prior to registration\n  * Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \\> 14 days from first dose of vaccination on study\n* CTCAE \\>= Grade 3 treatment-emergent adverse event (TEAE) to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity\n* Neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or history of rhabdomyolysis\n* Active ADs that require chronic systemic steroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive agents\n* Systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications =\\\u003C 14 days prior to registration\n\n  * NOTE: Inhaled or topical steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent permitted in absence of active AD\n* Evidence of leptomeningeal disease or central nervous system metastases that are untreated, symptomatic, or require steroids \\>10 mg daily prednisone equivalent\n\n  * NOTE: Patients with history of stable treated brain metastases are eligible. Stable treated metastases defined as no evidence of progression for ≥4 weeks on brain imaging (MRI or CT scan)\n\nPHASE II PRE-SCREENING:\n\n* Uncontrolled illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Congestive heart failure with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy =\\\u003C 3 years prior to pre-screening\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If there is history of prior malignancy, they must not be receiving other specific treatment for their cancer\n* Known history of active AD that has required systemic treatment in the =\\\u003C 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-screening\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.\n\nPHASE II PRE-REGISTRATION\n\n* Uncontrolled illness including, but not limited to:\n\n  * Congestive heart failure with NYHA class III or IV; moderate to severe objective evidence of cardiovascular disease\n  * Significant cardiac arrhythmia or unstable angina\n  * Any other conditions that would limit compliance with study requirements\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* Other active malignancy =\\\u003C 3 years prior to pre-registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix\n  * NOTE: If history of prior malignancy, must not be receiving other specific treatment for cancer\n* Known history of active AD that has required systemic treatment in the =\\\u003C 30 days (i.e., with use of disease modifying agents, corticosteroids \\> 10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to pre-registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.\n* Patients will also be excluded based on tissue\u002Fribonucleic acid (RNA)\u002Fdeoxyribonucleic acid (DNA) quality and quantity. If any of the following quality and quantity thresholds are not met, patient will be excluded: (1) tumor tissue cellularity equal to or greater than 30%; (2) there are \\>= 2 cores with passing cellularity; (3) \\>= 30% of tumor RNA with fragment sizes are \\>= 200 base pairs (DV200 \\>= 30); (4) \\\u003C 10% of DNA fragments are smaller than 1 kb; and (5) sufficient amount of both DNA (blood and tumor) and RNA (tumor) for exome sequencing and whole transcriptome sequencing (RNAseq) according to Mayo sequencing core. (Kits and technologies change overtime, so these are not fixed numbers.)\n\nPHASE II REGISTRATION\n\n* Evidence of metastatic disease or recurrence\n* Any of the following prior therapies:\n\n  * Chemotherapy, experimental drugs (except pembrolizumab), or small molecules inhibitors (except for endocrine therapies) =\\\u003C 3 weeks prior to registration\n  * Radiation =\\\u003C 2 weeks prior to registration\n  * Major surgery =\\\u003C 4 weeks prior to registration\n  * Received live vaccine =\\\u003C 30 days prior to registration\n\n    * NOTE: Continuation of pembrolizumab per standard of care is allowed\n    * NOTE: Palliative radiation therapy for symptoms control including, but not limited to, bone metastatic lesion radiation therapy is allowed, but last dose of radiation therapy should be \\> 14 days from first dose of vaccination on study\n* CTCAE \\>= grade 3 TEAE to prior checkpoint inhibitor, TEAE requiring systemic corticosteroids (\\> 10 mg daily prednisone equivalent), or permanent treatment discontinuation due to toxicity\n* Neuromuscular disorders (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy), or history of rhabdomyolysis\n* Active ADs that require chronic systemic steroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive agents\n* Requirement for systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications =\\\u003C 14 days prior to registration\n\n  * NOTE: Inhaled or topical steroids and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted in","16 Years",{"count":81,"type":21},132,[83,84],"PHASE1","PHASE2","This phase I\u002FII trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain proteins (neoantigens) on individuals' tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving the personalized neoantigen peptide-based vaccine with pembrolizumab may be safe and effective in treating patients with advanced solid tumors.",[87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,25,173,174,175,176,177,178,179,180,181,182,183,184,185],"Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage III Merkel Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Merkel Cell Carcinoma AJCC v8","Clinical Stage IVA Gastric Cancer AJCC v8","Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVB Gastric Cancer AJCC v8","Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Locally Advanced Cervical Carcinoma","Locally Advanced Endometrial Carcinoma","Locally Advanced Gastric Adenocarcinoma","Locally Advanced Gastroesophageal Junction Adenocarcinoma","Locally Advanced Head and Neck Squamous Cell Carcinoma","Locally Advanced Hepatocellular Carcinoma","Locally Advanced Lung Non-Small Cell Carcinoma","Locally Advanced Malignant Solid Neoplasm","Locally Advanced Melanoma","Locally Advanced Merkel Cell Carcinoma","Locally Advanced Renal Cell Carcinoma","Locally Advanced Skin Squamous Cell Carcinoma","Locally Advanced Triple-Negative Breast Carcinoma","Locally Advanced Unresectable Breast Carcinoma","Locally Advanced Unresectable Cervical Carcinoma","Locally Advanced Unresectable Gastric Adenocarcinoma","Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma","Locally Advanced Unresectable Renal Cell Carcinoma","Locally Advanced Urothelial Carcinoma","Metastatic Cervical Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Gastric Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Metastatic Merkel Cell Carcinoma","Metastatic Renal Cell Carcinoma","Metastatic Skin Squamous Cell Carcinoma","Metastatic Triple-Negative Breast Carcinoma","Metastatic Urothelial Carcinoma","Skin Squamous Cell Carcinoma","Stage III Cervical Cancer AJCC v8","Stage III Hepatocellular Carcinoma AJCC v8","Stage III Lung Cancer AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage IIIA Cervical Cancer AJCC v8","Stage IIIA Hepatocellular Carcinoma AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIA Uterine Corpus Cancer AJCC v8","Stage IIIB Cervical Cancer AJCC v8","Stage IIIB Hepatocellular Carcinoma AJCC v8","Stage IIIB Lung Cancer AJCC v8","Stage IIIB Uterine Corpus Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Stage IIIC Uterine Corpus Cancer AJCC v8","Stage IIIC1 Uterine Corpus Cancer AJCC v8","Stage IIIC2 Uterine Corpus Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IVA Cervical Cancer AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVB Cervical Cancer AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","Stage IVB Lung Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","Triple-Negative Breast Carcinoma","Unresectable Cervical Carcinoma","Unresectable Endometrial Carcinoma","Unresectable Gastric Adenocarcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma","Unresectable Head and Neck Squamous Cell Carcinoma","Unresectable Lung Non-Small Cell Carcinoma","Unresectable Malignant Solid Neoplasm","Unresectable Melanoma","Unresectable Merkel Cell Carcinoma","Unresectable Renal Cell Carcinoma","Unresectable Skin Squamous Cell Carcinoma","Unresectable Triple-Negative Breast Carcinoma","Unresectable Urothelial Carcinoma","Breast Adenocarcinoma","Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","2026-06-18",{"date":60,"type":32},{"date":189,"type":32},"2022-03-31",{"date":191,"type":21},"2028-03-31",{"name":193,"class":69},"Mayo Clinic",{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":51,"phases":203,"briefSummary":204,"conditions":205,"keywords":209,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100610394","phase-1-symbiotic-gi-13-a-study-to-learn-about-study-medicine-called-pf-08634404-as-a-single-treatment-and-combination-treatment-in-adult-participants-with-a-liver-cancer-called-hepatocellular-carcinoma-that-is-too-advanced-to-be-removed-by-surgery-and-may-have-spread-to-other-parts-of-the-body-100610394","NCT07227012","Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.","AN INTERVENTIONAL OPEN-LABEL PHASE 1B\u002F2 STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 AS MONOTHERAPY AND COMBINATION THERAPY IN ADULT PARTICIPANTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Locally advanced or metastatic HCC with diagnosis confirmed by histology\u002Fcytology or clinically by AASLD criteria (for patients with cirrhosis). Participants without cirrhosis require histological confirmation of diagnosis.\n* Disease that is not amenable to curative surgical and\u002For locoregional therapies, or progressive disease after surgical and\u002For locoregional therapies.\n* At least 1 measurable (as defined by RECIST 1.1 per investigator) and untreated lesion.\n* Adequate hepatic, liver, and renal function\n* No prior systemic therapy for HCC.\n* ECOG performance status 0 or 1\n* Child-Pugh Class A\n\nKey Exclusion Criteria:\n\n* Moderate or severe ascites.\n* History of hepatic encephalopathy.\n* Participants with known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.\n* Clinically significant risk of hemorrhage or fistula.\n* Participants with any history of another malignancy within 3 years.\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years.\n* Clinically significant cardiovascular disease within 6 months prior to the first dose.\n* Major surgery or severe trauma within 4 weeks prior to the first dose or planned major surgery during the study.\n* History of severe bleeding tendency or coagulation dysfunction.\n* History of severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding, including bleeding event due to esophageal and\u002For gastric varices, within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections.\n* Participants with history of immunodeficiency.",{"count":202,"type":21},138,[83,84],"The purpose of this study is to learn about the effects of study medicine (PF-08634404) when given alone or with another antibody (ipilimumab) for the treatment of a type of liver cancer called hepatocellular carcinoma (HCC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have locally advanced or metastatic HCC.\n* Is not a candidate for complete surgical or loco-regional therapies.\n* Have not received any whole-body treatment for HCC.\n\nParticipants will receive PF-08634404 either alone or in combination with ipilimumab. The medicine will be given through intravenous (IV) infusions, which means it will be administered directly into a vein. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.",[206,57,56,25,207,208,128],"Carcinoma, Hepatocellular","Liver Neoplasms","Advanced Hepatocellular Carcinoma",[56,210,207],"Liver cancer","2026-06-03",{"date":213,"type":32},"2026-06-04",{"date":215,"type":32},"2025-12-01",{"date":217,"type":21},"2028-10-17",{"name":219,"class":39},"Pfizer",35,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":51,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":70},"100358074","phase-1-modified-immune-cells-autologous-dendritic-cells-and-a-vaccine-prevnar-combined-with-immune-checkpoint-inhibition-after-high-dose-external-beam-radiation-therapy-in-treating-patients-with-unresectable-liver-cancer-100358074","NCT03942328","Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer","MC1641 Phase II Study Of Intratumoral Injection Of Autologous Dendritic Cells Combined With Immune Checkpoint Inhibition After High-Dose Conformal External Beam Radiotherapy In Patients With Unresectable Primary Liver Cancer","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Pilot study (group 1): Histologic confirmation of intrahepatic CCA (Closed as of amendment 3)\n* Phase II study (group 2): Histologic and\u002For radiologic confirmation of hepatocellular carcinoma (HCC)\n* Phase II study (group 3): Histologic confirmation of intrahepatic cholangiocarcinoma (iCCA)\n* The following tumor characteristics must be met\n\n  * Unresectable disease: HCC (group 2) or intrahepatic CCA (group 3)\n  * Measurable or evaluable disease\n  * All lesions should be treatable by EBRT while meeting normal tissue constraints\n  * Tumor lesions should be accessible using an ultrasound (US)-guided approach for intratumoral DC injection\n  * No evidence of extrahepatic tumor (excluding tumor thrombus) by computed tomography (CT) or magnetic resonance imaging (MRI) scan\n\n    * NOTE: Patients who are not candidates for surgical treatment or for ablation with curative intent are allowed\n* Good candidate for standard of care high-dose conformal EBRT in the view of the investigator\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* GROUP 2 HCC ONLY: Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Absolute lymphocyte count (ALC) \\>= 500\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Absolute monocyte count (AMC) \\>= 300\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Platelet count \\>= 50,000\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Hemoglobin \\>= 9.0 g\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Total bilirubin \\\u003C 1.5 mg\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 5 x upper limit of normal (ULN) (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Creatinine =\\\u003C 2 mg\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Prothrombin time (PT)\u002Finternational normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* GROUP 2 HCC ONLY: Absence of proteinuria at screening as demonstrated by one of the following:\n\n  * Urine protein\u002Fcreatinine (UPC) ratio \\\u003C 1.0 at screening OR\n  * Urine dipstick for proteinuria \\\u003C 2+ (patients discovered to have \\>= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate =\\\u003C1g of protein in 24 hours to be eligible)\n* GROUP 3 iCCA ONLY: Absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: Absolute lymphocyte count ≥ 500\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: Absolute monocyte count ≥ 300\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: Platelet count ≥ 50,000\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: Hemoglobin ≥ 9.0 g\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: Total bilirubin \\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: Creatinine ≤ 2 mg\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* GROUP 3 iCCA ONLY: PT\u002FINR\u002FaPTT ≤ 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n\n  * NOTE: If patient is receiving therapeutic anticoagulation, patient must be on a stable anticoagulant regimen\n* Ability to provide written consent\n* Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Willingness to provide blood and tissue samples for correlative research purposes\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ highly effective contraception during heterosexual intercourse while on this study and for 5 months after the last dose of study medication\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Immunocompromised patients and patients known to be HIV positive.\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial if they are stable on anti-retroviral therapy, have a CD4+ T cell count ≥ 200\u002FuL, and have an undetectable viral load\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection requiring systemic treatment or that could impact patient safety\n  * Severe infection ≤ 4 weeks prior to registration, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n  * Significant cardiovascular disease (New York Heart Association \\[NYHA\\] class II), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia\n  * Or, psychiatric illness\u002Fsocial situations (e.g., substance abuse) that would limit compliance with study requirements\n* Receiving any other investigational agent that would be considered a treatment for the primary neoplasm\n* Other active malignancy =\\\u003C 1 year prior to registration that is considered by the investigator to interfere with the current treatment or measurement of outcomes\n* Major surgery =\\\u003C 4 weeks prior to enrollment (other than diagnostic surgery or surgical spacer placement in preparation for radiation treatment), or anticipation of need for a major surgical procedure during the study\n* History of hypersensitivity or anaphylactoid reactions to pneumococcal vaccine or any component of the formulation, including diphtheria toxoid\n* Active or history of autoimmune disease or immune deficiency, including but not limited to,myasthenia gravis, myositis, autoimmune hepatitis, Crohn's disease, inflammatory bowel disease, antiphospholipid antibody syndrome, rheumatoid arthritis, Sjogren syndrome, systemic lupus erythematosus, Guillain-Barre syndrome, multiple sclerosis, Wegener granulomatosis, or similar conditions\n\n  * NOTE: Exceptions are allowed for:\n\n    * Patients with hypothyroidism on thyroid replacement therapy\n    * Patients with type 1 diabetes mellitus on insulin regimen\n    * Patients with eczema, psoriasis lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of the following conditions are met:\n\n      * Rash must cover \\\u003C 10% of body surface area\n      * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n      * There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids ≤ 12 months prior to registration\n* Requires anticoagulant treatment (INR \\> 1.5 x ULN) or use of anti-platelet agents that cannot be discontinued for the intratumoral injection procedure\n\n  * NOTE: Heparin for line patency without detectable lab abnormalities in coagulation will be allowed\n* Corticosteroids =\\\u003C 2 weeks prior to registration, including oral, intravenous (IV), subcutaneous, or inhaled routes of administration\n\n  * NOTE: Patients on chronic corticosteroids for adrenal insufficiency or other reasons may enroll if they receive less than 10 mg\u002Fday of prednisone (or equivalent)\n  * NOTE: Exception allowed for patients who need prophylactic steroids prior to imaging for contrast allergies\n\n    * Exception: Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study\n    * Exception: Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study\n* History of myocardial infarction =\\\u003C 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Child Pugh class B or C cirrhosis of the liver\n* Previously received immune modulating therapies including but not limited to immune checkpoint inhibitors targeting PD-1 PDL-1 CTLA4, etc.; or prior dendritic cell therapy\n* Prior liver radiation, including radioembolization\n* GROUP 2 ONLY: Barcelona Clinic Liver Cancer (BCLC) stage D disease\n* GROUP 2 ONLY: History of untreated high-risk gastroesophageal varices\n* Active tuberculosis\n* Treatment with therapeutic oral or IV antibiotics ≤ 2 weeks prior to registration\n\n  * NOTE: Exception for patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study\n* Prior allogeneic stem cell or solid organ transplantation\n* Treatment with a live, attenuated vaccine ≤ 4 weeks prior to registration",{"count":229,"type":21},85,[83,84],"This early phase I trial studies the side effects of autologous dendritic cells and a vaccine called Prevnar in combination with immune checkpoint inhibition (with bevacizumab and atezolizumab or druvalumab) in treating patients liver cancer that cannot be removed by surgery (unresectable) after undergoing standard high-dose external beam radiotherapy. Autologous dendritic cells are immune cells generated from patients' own white blood cells that are grown in a special lab and trained to stimulate the immune system to destroy tumor cells. A pneumonia vaccine called Prevnar may also help stimulate the immune system. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Immunotherapy with monoclonal antibodies, such as atezolizumab and durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving autologous dendritic cells and Prevnar in combination with immune checkpoint inhibition after radiotherapy may be safe, and tolerable and may stimulate the body's own immune system to fight against the tumor in patients with unresectable liver cancer.",[139,233,156,234,25,235],"Stage III Intrahepatic Cholangiocarcinoma AJCC v8","Stage IV Intrahepatic Cholangiocarcinoma AJCC v8","Unresectable Intrahepatic Cholangiocarcinoma","2026-04-16",{"date":238,"type":32},"2026-04-20",{"date":240,"type":32},"2019-09-19",{"date":242,"type":21},"2029-08-31",{"name":193,"class":69},{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":51,"phases":254,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":70},"100553390","phase-3-tace-plus-camrelizumab-and-apatinib-for-unresectable-hepatocellular-carcinoma-100553390","NCT06485466","TACE Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma","Transarterial Chemoembolization Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma : a Randomised , Open Label, Multicenter Controlled Trial","Inclusion Criteria:\n\n1. Histopathologically or clinically confirmed hepatocellular carcinoma\n2. 18-80 years old.\n3. Performance status (PS) ≤ 1 (ECOG scale).\n4. Barcelona clinical liver cancer (BCLC) stage B or stage C.\n5. Initial treatment of hepatocellular carcinoma.\n6. According to mRECIST, there is at least one measurable lesion.\n7. Child Pugh score ≤ 7.\n8. Participant has sufficient organ and marrow functions.\n9. Expected survival time ≥ 12 weeks.\n10. For women of childbearing age or male patients whose sexual partners are women of childbearing age, effective contraceptive measures should be taken during the whole treatment period and 6 months after the last medication.\n11. Sign the written informed consent, and be able to follow the visit and relevant procedures specified in the plan.\n\nExclusion Criteria:\n\n1. Fibrolamellar carcinoma, sarcomatoid carcinoma, cholangiocarcinoma and other components previously confirmed by histology \u002F cytology.\n2. History of hepatic encephalopathy or liver transplantation.\n3. Pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage.\n4. Tumor burden≥70%, diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.\n5. Received local treatment (ablation therapy, TACE), surgery resection and radiotherapy for liver cancer before the first administration.\n6. Have received systemic chemotherapy, targeted therapy or immunotherapy\n7. There is a significant decrease in white blood cells and platelets in peripheral blood, severe coagulation dysfunction and can not be corrected：the neutrophil\\\u003C1.5×109\u002FL, PLT\\\u003C50×109\u002FL. The INR\\>2.3\n8. Acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV-DNA) \\> 10\\^6 copies \u002F ml; hepatitis C virus (HCV-RNA) \\> 10\\^3 copies \u002F ml; HBsAg and anti HCV antibody were positive at the same time.\n9. There is central nervous system metastasis.\n10. Bleeding of esophageal or gastric varices caused by portal hypertension occurred in the past 6 months, or severe (G3) varices were found in endoscopic examination within 3 months before the first administration, or evidence of portal hypertension (including splenomegaly found in imaging examination) was found. The researchers assessed that the risk of bleeding was high and did not receive sclerotherapy or ligation under the endoscope.\n11. The previous 6-month history of arteriovenous thromboembolism, including myocardial infarction, unstable angina, cerebrovascular accident, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism. The thrombus of implanted vein port or catheter source or superficial vein is stable after routine anticoagulant treatment. Prophylactic use of low-molecular-weight heparin (e.g., enoxaparin 40 mg \u002F day) is permitted.\n12. Tumor thrombus of main portal vein, or involving superior mesenteric vein at the same time.\n13. Aspirin (\\> 325 mg \u002F day) or other drugs known to inhibit platelet function such as dipyridamole or clopidogrel were used for 7 consecutive days within 2 weeks before the first administration.\n14. For uncontrolled hypertension, systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg after the best medical treatment, hypertension crisis or hypertension encephalopathy history.\n15. Symptomatic congestive heart failure (New York Heart Association class II-IV). Symptomatic or poorly controlled arrhythmias. The corrected QT interval (QTc) for the history or screening of congenital long QT syndrome was more than 500 ms (calculated by Fridericia method).\n16. Serious bleeding tendency or coagulation dysfunction, or undergoing thrombolysis.\n17. In the past 6 months, there was a history of gastrointestinal perforation and \u002F or fistula, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive enterotomy (partial colectomy or extensive enterotomy with chronic diarrhea), Crohn's disease, ulcerative colitis or long-term chronic diarrhea.\n18. Previous and current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function and other lung diseases.\n19. Active tuberculosis (TB), who is receiving anti TB treatment or has received anti TB treatment within one year before the first administration.\n20. People with HIV infection (HIV 1 \u002F 2 antibody positive) and known syphilis infection. Serious infection in active stage or poor clinical control.\n21. Severe infection within 4 weeks before the first administration, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia.\n22. Active autoimmune diseases requiring systemic treatment (such as the use of disease alleviation drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapies (e.g. thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are permitted. Known history of primary immunodeficiency. Only the patients with positive autoimmune antibody need to confirm whether there is autoimmune disease according to the judgment of researchers.\n23. Immunosuppressive drugs were used within 4 weeks before the first administration, excluding local glucocorticoids or systemic glucocorticoids (i.e.\n\n    no more than 10 Mg \u002F day prednisone or the equivalent dose of other glucocorticoids), allowing temporary use of glucocorticoids due to dyspnea symptoms in the treatment of asthma, chronic obstructive pulmonary disease and other diseases.\n24. Receive live attenuated vaccine within 4 weeks before the first administration or during the study period.\n25. Major surgical procedures (craniotomy, thoracotomy or open hand) were performed within 4 weeks before the first administration (surgery) or an unhealed wound, ulcer, or fracture.\n26. Uncontrolled \u002F uncorrectable metabolic disorder or other non- malignant organ disease or systemic disease or cancer secondary reaction, which may lead to higher medical risk and \u002F or uncertainty of survival evaluation.\n27. Known to be allergic to any PD-1 monoclonal antibody component.\n28. Women of childbearing age who are unwilling or unable to use acceptable methods of contraception during the whole treatment period of this trial and within 12 weeks after the last administration of the study drug (women of childbearing age include: any women who have had menarche, and have not undergone successful artificial sterilization (hysterectomy, bilateral tubal ligation, or bilateral ovariectomy), pregnancy or lactation Women; women with positive pregnancy test results at the time of inclusion or before study drug administration; If the partner is a woman of childbearing age, the subject is a fertile male without effective contraceptive measures.","80 Years",{"count":253,"type":21},101,[255],"PHASE3","Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most common cause of cancer-related death worldwide. The majority of patients with HCC are diagnosed as intermediate or advanced stage disease, and not eligible for curative treatments including transplantation, resection, and ablation. Transarterial chemoembolization (TACE) is recommended as first-line treatment for patients with intermediate-stage HCC, while it is also widely used in the unresectable HCC.\n\nThe clinical efficacy and safety in advanced HCC patients of camrelizumab plus apatinib were reported in phase 3 trial (CARES-310). Camrelizumab plus apatinib with a median progression-free survival of 5.7 months and a median overall survival of 22.1 months in advanced HCC.\n\nThis study is randomized, open-label, multicenter controlled trial; which was focused in initial BCLC-B\u002FC HCC patients. This study aimed to compare the efficacy and safety of TACE plus programmed death-1 inhibitor (camrelizumab), and anti-angiogenic therapy (apatinib) with camrelizumab plus apatinib.",[25,258,259,260],"Transarterial Chemoembolization","Camrelizumab","Apatinib","2026-04-12",{"date":263,"type":32},"2026-04-14",{"date":265,"type":32},"2024-08-10",{"date":267,"type":21},"2028-06-30",{"name":269,"class":69},"Guohui Xu",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":51,"phases":279,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":70},"100632270","phase-2-y-90-radioembolization-durvalumab-tremelimumab-and-zanzalintinib-for-the-treatment-of-unresectable-and-locally-advanced-hepatocellular-carcinoma-100632270","NCT07511504","Y-90 Radioembolization, Durvalumab, Tremelimumab, and Zanzalintinib for the Treatment of Unresectable and Locally-Advanced Hepatocellular Carcinoma","A Phase II Study to Evaluate the Efficacy and Safety of Y-90, Durvalumab, Tremelimumab, and Zanzalintinib in Patients With Unresectable and Locally-Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Participant must provide written informed consent before any study-specific procedures or interventions are performed\n* Participants aged ≥ 18 years\n* Body weight \\> 30 kg\n* Patients must have radiologically, or histologically or cytologically confirmed hepatocellular cancer that is not amenable to transplant or resection:\n\n  * Barcelona Clinic Liver Cancer Stage B or C\n  * Cirrhosis grade of Child-Pugh (CP) A or CP-B7 (excluding albumin-bilirubin \\[ALBI\\] grade 3)\n  * Fibrolamellar and mixed hepatocellular\u002Fcholangiocarcinoma subtypes are not eligible\n* Disease must not be amenable to surgical resection, transplantation, or thermal ablation, or recurrent hepatocellular carcinoma (HCC) after a previous definitive therapy (surgery or thermoablative therapy)\n* Venous invasion (portal, hepatic, biliary) and infiltrative growth pattern are eligible\n* Eligible for Y-90 transarterial radioembolization (TARE) based on planning angiogram, with evidence of:\n\n  * ≥ 30% hepatic reserve (i.e., untreated background liver) AND\n  * Estimated lung exposure \\\u003C 30 Gy\u002F treatment (or 50 Gy cumulative total)\n* Patients with bi-lobar disease amenable to simultaneous or sequential TARE are eligible\n* Eastern Cooperative Oncology Group (ECOG) 0 - 1 at enrollment\n* Recovery to baseline or ≤ grade 1 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\] 5.0) from toxicities related to any prior treatments, unless adverse events (AE\\[s\\]) are clinically non-significant and\u002For stable on supportive therapy\n* Hemoglobin ≥ 9 g\u002FdL (≥ 90 g\u002FL) (within 14 days before first dose of study treatment)\n* White blood cell count ≥ 2500\u002FμL (within 14 days before first dose of study treatment)\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL (1500\u002FμL), without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection (within 14 days before first dose of study treatment)\n* Platelet count ≥ 75 × 10\\^9\u002FL (≥ 75,000\u002FμL), without transfusion within 2 weeks of screening laboratory sample collection (within 14 days before first dose of study treatment)\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN) (within 14 days before first dose of study treatment)\n* Alkaline phosphatase (ALP) ≤ 5 x ULN (within 14 days before first dose of study treatment)\n* Total bilirubin ≤ 2 mg\u002FdL (≤ 34.2 μmol\u002FL) or \\\u003C 2 x ULN, whichever is higher (within 14 days before first dose of study treatment)\n* Serum albumin ≥ 2.8 g\u002FdL (within 14 days before first dose of study treatment)\n* International normalized ratio (INR) ≤ 1.7 x laboratory ULN (within 14 days before first dose of study treatment)\n* Stable renal function defined as serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance (CrCL) ≥ 40mL\u002Fmin (≥ 0.675mL\u002Fsec) using the Cockcroft-Gault equation (within 14 days before first dose of study treatment)\n* Urine protein\u002Fcreatinine ratio (UPCR) ≤ 1 mg\u002Fmg (≤ 113.2 mg\u002Fmmol), or 24-h urine protein ≤ 1 g (within 14 days before first dose of study treatment)\n* Has at least one measurable target lesion based on modified Response Evaluation Criteria in Solid Tumors (mRECIST)\n* Participants must have at least one lesion that is amendable to biopsy\n* Participant are asked to consent to tumor biopsies for biomarker analysis of the acquired tissue at the following timepoints: pre-treatment, on-treatment (i.e., after completing the initial combination cycle of durvalumab, tremelimumab and zanzalintinib), and at time of disease progression. These biopsies are optional and are not required for study participation\n* Sexually active fertile participants and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for:\n\n  * 96 days for sperm-producing participants or\n  * 186 days for participants of child-bearing potential (POCBP) after the last dose of zanzalintinib. Additionally, sperm-producing participants must agree not to donate sperm and POCBP must agree to not donate eggs (ova, oocyte) for the purpose of reproduction during these same periods\n* POCBP must not be pregnant at screening. POCBP participants are considered to be of childbearing potential unless one of the following criteria is met:\n\n  * Documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes.\n  * Participants \\\u003C 55 years-of-age must have a serum follicle stimulating (FSH) level \\> 40 mIU\u002FmL to confirm menopause).\n\n    * Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site\n\nExclusion Criteria:\n\n* Another primary tumor\n* Extrahepatic metastases\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.\n\n  * Note: Eligible participants must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment.\n  * Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed\n* Prior systemic therapy for HCC\n* Prior Y-90 radioembolization\n\n  * Note: prior transarterial chemoembolization is permitted if \\> 6 months prior to enrollment\n* Advanced liver disease with a CP-B7 (ALBI grade 3), CP-B8, CP-B9 or CP- C, or active gastrointestinal bleeding or encephalopathy or refractory ascites\n* Radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible\n* Prior treatment with an anti-PD-1, anti-PD-L1, or anti-CTLA4 agent, or with an agent directed to another co-inhibitory T-cell receptor (e.g., TIGIT, LAG-3, TIM-3)\n* Prior treatment with zanzalintinib, cabozantinib, or similar class of multitargeted Tyrosine Kinase Inhibitor (mTKI)\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment\n* Participants cannot be on other forms of anti-cancer therapy at the same time, except as described within this protocol\n* Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitors (e.g., rivaroxaban), or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:\n\n  * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low dose low molecular weight heparins (LMWH).\n  * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in participants without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\n    * Note: participants must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer\n* Any complementary medications (e.g., herbal supplements or traditional medicines) to treat their HCC under study within 2 weeks before first dose of study treatment\n* Participant has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Unstable of deteriorating cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class 3 or 4, class 2 or higher, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes).\n    * Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other clinically significant arterial thrombotic and\u002For ischemic event within 6 months before first dose of study treatment.\n    * Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment.\n\n      * Note: Participants with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n      * Note: Participants who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator.\n    * Prior history of myocarditis\n* Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n  * Participant has evidence of tumor invading the GI tract,\n  * Active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis\n  * Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic\n  * Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment.\n\n    * Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n  * Known gastric or esophageal varices that are untreated or incompletely treated with bleeding or high risk for bleeding. Participants treated with adequate endoscopic therapy (according to institutional standards) without any episodes of recurrent GI bleeding requiring transfusion or hospitalization for at least 6 months prior to study entry are eligible.\n  * Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks\n* Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before start of study intervention\n* Lesions invading a major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. Participants with lesions invading the hepatic portal vasculature are eligible\n* Elevated lung shunting precluding safe treatment with Y-90 within acceptable thresholds of lung exposure, defined as \\> 30 Gy\u002Ftreatment or 50 Gy total for multiple treatments\n* Patients with future liver remnant volume \\\u003C 30% after Y-90 treatment\n* Patients in whom Y-90 is deemed unsafe due to risks of extra-pulmonary non-target embolization\n* Any deposition to the GI tract (per 99mTc-MAA SPECT-CT or Cone Beam CT)\n* Hepatic artery catheterization is contraindicated (e.g., vascular abnormalities or bleeding diathesis)\n* Severe liver dysfunction, including hepatic encephalopathy, clinically evident ascites or treatment with diuretics for ascites\n* Type Vp4 Portal vein tumor thrombosis (PVTT) involvement and lack of Tc-99m MAA deposition on the PVT per Tc-99m MAA SPECT\u002FCT\n* Participants with renal failure currently requiring dialysis of any kind are not eligible\n* Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation\n* Known allergy or hypersensitivity to any of the study drug or any of the study drug excipients\n* Other clinically significant disorders that would preclude safe study participation.\n\n  * Active infection requiring systemic treatment.\n\n    * Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.\n  * Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness except for participants meeting all of the following criteria:\n\n    * On stable anti-retroviral therapy;\n    * CD4+ T cell count ≥ 200\u002FµL; and\n    * An undetectable viral load.\n\n      * Note: HIV testing is to be performed at screening if and as required by local regulation.\n      * Note: To be eligible, participants taking CYP inhibitors (e.g., zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose.\n      * Note: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider\n  * Uncontrolled hepatitis B Virus (HBV) infection. Participants with controlled hepatitis B virus (HBV), defined as receiving effective antiviral therapy and adequate viral suppression (i.e., HBV deoxyribonucleic acid \\[DNA\\] ≤ 2000 IU\u002FmL) are eligible.\n\n    * Note: participants must meet liver function inclusion parameters (i.e., ALT, AST, bilirubin)\n  * Hepatitis C (HCV) infection. Participants with active, controlled HCV infection are eligible provided liver function meets eligibility criteria and are receiving management of the disease per local institutional practice.\n  * Serious non-healing wound\u002Fulcer\u002Fbone fracture.\n\n    * Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n  * Malabsorption syndrome\n  * Pharmacologically uncompensated, symptomatic hypothyroidism.\n  * Requirement for hemodialysis or peritoneal dialysis.\n  * History of solid organ or allogenic stem cell transplant\n* Major surgery (e.g., GI surgery) within 8 weeks before first dose of study treatment. Minor surgeries (e.g., simple excision) within 5 days before first dose of study treatment. Participants must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Participant with clinically relevant ongoing complications from prior surgery are not eligible\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 470 ms per electrocardiogram (ECG) within 14 days before first dose of study treatment. Participants with a history of additional risk factors for torsades de pointes (e.g., long QT syndrome) are also excluded \\[add reference for Fridericia formula\\].\n\n  * Note: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility\n* Any active, known or suspected autoimmune disease will be excluded, with the following exceptions:\n\n  * Type 1 diabetes mellitus.\n  * Hypothyroidism only requiring hormone replacement.\n  * Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment.\n  * Conditions not expected to recur in the absence of an external trigger\n* Known positive test for tuberculosis infection if supported by clinical or radiographic evidence of disease\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computerized tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Free thyroxine outside the laboratory normal reference range. Asymptomatic participants with free thyroxine abnormalities are eligible per investigator's discretion\n* Any condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before first dose of study treatment. Note the following exceptions:\n\n  * Inhaled, intranasal, intra-articular, or topical steroids are permitted.\n  * Adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.\n  * Transient short-term use of systemic corticosteroids for allergic conditions (e.g., contrast allergy) is permitted\n* Prior allogeneic stem cell or solid organ transplantation\n* Receipt of a live, attenuated vaccine within 30 days prior to enrollment\n* Documented hepatic encephalopathy within 6 months before first dose of study treatment\n* Clinically meaningful ascites (i.e., ascites requiring paracentesis or escalation in diuretics) within 6 months before first dose of study treatment\n* Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, safety of participation, or interpretation of results. This includes significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome) or any other serious medical condition or abnormality in clinical laboratory tests that meet these criteria in the investigator's opinion\n* Patient is pregnant or lactating\n* Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube, or unwillingness or inability to receive IV administration\n* Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 2 years prior to first dose of study treatment that requires active treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6\n* History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent\n* Participants with any condition that, in the opinion of the investigator, could jeopardize the participant's safety or adherence to the study protocol",{"count":278,"type":21},40,[84],"This phase II trial tests how well giving Y-90 radioembolization, durvalumab, tremelimumab and zanzalintinib works for the treatment of hepatocellular carcinoma that cannot be removed by surgery (unresectable) and that has spread to nearby tissue or lymph nodes (locally advanced). Y-90 radioembolization is a therapy that injects radioactive particles directly into an artery that feeds liver tumors to cut off their blood supply. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Zanzalintinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Y-90 radioembolization, durvalumab, tremelimumab and zanzalintinib may be effective for treating unresectable and locally-advanced hepatocellular carcinoma.",[109,139,156,25],"2026-03-30",{"date":284,"type":32},"2026-04-06",{"date":286,"type":21},"2026-04-02",{"date":288,"type":21},"2027-08-01",{"name":290,"class":69},"OHSU Knight Cancer Institute",{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":251,"enrollmentInfo":298,"targetDuration":4,"studyType":51,"phases":300,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":316,"locationsCount":70},"100630006","phase-1-a-multicenter-clinical-study-of-combined-therapy-for-unresectable-hepatocellular-carcinoma-100630006","NCT07482059","A Multicenter Clinical Study of Combined Therapy for Unresectable Hepatocellular Carcinoma","A Multicenter Phase Ib\u002FII Clinical Study on the Safety and Efficacy of Selective Internal Radiation Therapy (SIRT) With Yttrium-90 Microspheres in Combination With Nivolumab, Ipilimumab, and Lenvatinib in Patients With Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. HCC confirmed as unresectable by imaging or histology, or patients who refuse surgery. Eligible for Y90-SIRT, with no evidence of extrahepatic disease on any available imaging. Lymph node involvement is permitted. The term \"unresectable hepatocellular carcinoma\" refers to a clinical state in which radical surgical resection is precluded because the tumor extent or an inadequate anticipated future liver remnant would prevent R0 removal, or because the procedural risk is prohibitively high, and where surgical intervention is not expected to yield a survival advantage over non-surgical therapies.\n2. Aged between 18 and 80 years at the time of enrollment\n3. Participants with Child-Pugh class A.\n4. Participants with an ECOG performance status of 0 or 1 at the time of enrollment\n5. Participants with a lung dose threshold of 30 Gy for yttrium-90 microspheres (each treatment dose ≤ 30 Gy), and an anticipated future liver remnant volume (FLRV) ≥ 30% of the total liver volume.\n6. Participants with one or more measurable lesions; for those with segmental or right anterior\u002Fposterior portal vein invasion (Vp1\u002FVp2), the disease is confined to a single lobe and suitable for Y90 microsphere treatment.\n7. If the patient is co-infected with hepatitis B virus (HBV) or hepatitis C virus (HCV), the following criteria must be met: HBV or HCV viral levels should be monitored during study participation. Patients with detectable hepatitis B surface antigen (HBsAg) or HBV DNA should have HBV DNA \\\u003C 100 IU\u002Fml and be managed according to local treatment guidelines. Most patients with advanced HCC and HCV have not received treatment for HCV infection. However, if antiviral therapy has been completed prior to the first administration of study drugs, these patients are considered eligible for inclusion.\n8. No prior systemic therapy or transarterial radioembolization (Y90 glass microsphere TARE).\n9. No active autoimmune disease and no history of chronic or recurrent autoimmune disease.\n10. Adequate hematological, liver, and renal function as follows: (1) Absolute neutrophil count ≥ 1,500\u002Fmm³ (2) Hemoglobin level ≥ 9.0 g\u002FdL (3) Platelet count ≥ 75,000\u002Fmm³ (4) Total bilirubin ≤ 1.5 × ULN (5) AST ≤ 2.5 × ULN (6) ALT ≤ 2.5 × ULN (7) International normalized ratio (INR) ≤ 1.25 (8) Albumin ≥ 31 g\u002FL (9) 24-hour urine collection creatinine clearance (CL) \\> 40 mL\u002Fmin or calculated creatinine clearance (CL) \\> 40 mL\u002Fmin.\n11. Not pregnant and no intention to conceive before or during treatment.\n12. Written informed consent from the patient.\n13. Expected survival of at least 12 weeks.\n\nExclusion Criteria:\n\n1. Diffuse HCC or presence of vascular invasion or extrahepatic spread, with the following exceptions: invasion of segmental portal vein or hepatic vein.\n2. Patients with Child-Pugh class C cirrhosis.\n3. Any contraindication to hepatic arterial embolization: Known hepatic arterial reflux; known portosystemic shunt; coagulopathy (platelet count \\\u003C 50 × 109\u002FL, INR \\> 1.5); renal failure\u002Finsufficiency requiring hemodialysis or peritoneal dialysis; known severe arteriosclerosis; complete thrombosis or complete invasion of the main portal vein.\n4. History of heart disease: congestive heart failure \\> New York Heart Association (NYHA) class II; active coronary artery disease (CAD) (myocardial infarction ≥ 6 months prior to study initiation is permitted); arrhythmias that are difficult to control with antiarrhythmic drugs or require a pacemaker (NCI-CTCAE v5.0 \\> grade 2); uncontrolled hypertension; clinically significant gastrointestinal bleeding within 4 weeks prior to initiation of study drugs.\n5. Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism, occurring within 6 months prior to the first administration of study drug, except for segmental portal vein thrombosis.\n6. Receipt of systemic anticancer therapy, radiotherapy, endocrine therapy, immunotherapy, or other investigational drugs within 4 weeks prior to study initiation.\n7. Current or prior use of immunosuppressive drugs within 28 days before the first administration of nivolumab or ipilimumab. Exceptions to this criterion include: intranasal, inhaled, topical steroids or local steroid injections (e.g., intra-articular injection); physiological doses of systemic corticosteroids not exceeding 10 mg\u002Fday of prednisone or equivalent; steroids used for the prevention of allergic reactions (e.g., premedication for CT scan).\n8. Receipt of live attenuated vaccines within 30 days prior to the first administration of study drug (IP). Note: If the patient is enrolled, live vaccines should not be administered during the study drug treatment period and within 30 days after the last dose of the study drug.\n9. Major surgery within 4 weeks prior to study initiation, and the patient must have recovered from the effects of major surgery.\n10. Patients with a second primary malignancy, apart from adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix, unless disease-free for more than 3 years.\n11. Uncontrolled comorbidities, including but not limited to persistent or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease associated with diarrhea, or psychiatric\u002Fsocial conditions that limit compliance with study requirements, significantly increase the risk of adverse events, or impair the patient's ability to provide written informed consent.\n12. Active infections, including tuberculosis (clinical assessment including medical history, physical examination, and imaging, as well as tuberculosis testing according to local practice), hepatitis B (known positive HBV surface antigen \\[HBsAg\\]), and hepatitis C. Patients with past or resolved HBV infection (defined as presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients who are HCV antibody-positive are eligible only if HCV RNA measured by PCR is negative.\n13. History of allogeneic organ transplantation.\n14. Psychiatric disorders or altered mental status that interfere with understanding the informed consent process and\u002For compliance with the study protocol.\n15. Symptomatic brain metastases. If symptoms are present, imaging is required to confirm the absence of brain metastases.\n16. Pregnant or breastfeeding women.\n17. Immunocompromised patients, such as those known to be serologically positive for human immunodeficiency virus (HIV).\n18. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease \\[such as colitis or Crohn's disease\\], diverticulitis \\[excluding diverticulosis\\], systemic lupus erythematosus, sarcoidosis, or Wegener's granulomatosis \\[granulomatosis with polyangiitis\\], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, among others).\n19. Known allergy or hypersensitivity to any study drug or its components.\n20. Currently participating in or previously participated in a study involving an investigational drug, or use of an investigational device within 4 weeks prior to the first administration of study treatment.",{"count":299,"type":21},33,[83,84],"This clinical trial was designed to evaluate the safety and efficacy of Y90-SIRT combined with nivolumab, ipilimumab, and lenvatinib in patients with unresectable HCC. In addition to assessing short-term efficacy endpoints, such as ORR and PFS, this trial places particular emphasis on the OS benefit for patients. This study is therefore both novel and innovative.",[25],[304,305,306,307,308,309],"unresectable hepatocellular carcinoma","Yttrium-90 microsphere selective internal radiation therapy (Y90-SIRT)","nivolumab","pilimumab","lenvatinib","phase Ib\u002FII study","2026-03-15",{"date":312,"type":32},"2026-03-19",{"date":314,"type":21},"2026-02",{"date":267,"type":21},{"name":317,"class":69},"West China Hospital",{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":51,"phases":327,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":340},"100446690","phase-1-atezolizumabbevacizumabsbrt-in-unresectable-hcc-100446690","NCT05096715","Atezolizumab+Bevacizumab+SBRT in Unresectable HCC","Phase IB Study of Atezolizumab and Bevacizumab With SBRT for Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Participants must have diagnosis of hepatocellular carcinoma (HCC) that is deemed unsuitable for surgical resection, transplant, or radiofrequency ablation (RFA). Participants may have up to 5 lesions with a total maximal tumor dimension of \\\u003C 20 cm, and no one lesion \\> 15 cm. Diagnosis may be confirmed by at least 1 criteria listed below:\n\n  * Histologically or cytologically proven diagnosis of HCC within 180 days prior to study registration.\n  * At least 1 solid liver lesion or vascular tumor thrombus (involving portal vein, IVC, and\u002For hepatic vein) \\> 1 cm with arterial enhancement and delayed washout on multiphasic CT or MRI. Radiologic imaging evaluation must occur within 28 days prior to study registration.\n  * Enhancing vascular thrombosis demonstrating arterial enhancement and delayed washout of multiphasic MRI. Radiologic imaging evaluation must occur within 30 days prior to study registration.\n* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.\n* Small volume extrahepatic disease permitted, defined as \\\u003C2.0 cm in sum of maximal diameters (e.g. presence of one 1.8 cm metastatic lymph node, or two 0.8 cm lung lesions are allowed). Bony lesions are included in the \\\u003C2.0 cm of extrahepatic disease. Note that benign periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is \\> 2.0 cm. Radiologic imaging of chest, abdomen, and pelvis via CT or MRI is required within 28 days prior to study registration. CT with contrast is required unless contrast is contraindicated.\n* Participants may have received transarterial chemoembolization (TACE) or drug eluting beads (DEB). A 2 week (14 day) washout period is required prior to initiating study treatment.\n* Age ≥18 years at the time of signing informed consent document.\n* ECOG performance status 0-1.\n* Child-Pugh A liver function within 7 days of study registration.\n* Barcelona Clinic Liver Cancer (BCLC) stages Intermediate (B) or Advanced (C) within 7 days of study registration.\n* No evidence of significant portal hypertension.\n* Participants must have adequate organ and marrow function as defined the following laboratory results, obtained within 7 days prior to study registration:\n\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * absolute lymphocyte count ≥500\u002FmcL\n  * platelets ≥75,000\u002FmcL without transfusion\n  * hemoglobin ≥9 g\u002FdL, transfusion allowed to meet this criterion\n  * total bilirubin ≤ 3 × institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤5 × institutional ULN\n  * alkaline phosphatase(ALP) \\\u003C2 × institutional ULN\n  * creatinine ≤ 1.5 × institutional ULN OR\n  * estimated creatinine clearance ≥50 mL\u002Fmin\u002F1.73 m2 (according to the Cockcroft-Gault formula)\n  * serum albumin ≥2.8 g\u002FdL\n  * INR or aPTT ≤2 × institutional ULN for participants not receiving therapeutic anticoagulation\n  * Urine dipstick for proteinuria \\\u003C2+; participants discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate \\\u003C1g of protein in 24 hours.\n* Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade ≤ 1 prior to study entry, with the exception of alopecia.\n* No known HIV infection.\n* Documented virology status of hepatitis B virus (HBV), as confirmed by screening HBV serology test within 28 days prior to study registration.\n\n  * For participants with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n  * For participants with active HBV, HBV DNA \\\u003C500 IU\u002FmL obtained within 28 days prior to initiation of study treatment, and Anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study.\n* Documented virology status of hepatitis C virus (HCV), as confirmed by screening HCV serology test within 28 days prior to study registration.\n* Women of childbearing potential (WOCBP) must agree to use appropriate method(s) of contraception to avoid pregnancy during the treatment period and for at least 5 months after the last dose of Atezolizumab or 6 months after the last dose of Bevacizumab. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).\n* WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 14 days prior to study registration.\n* Women must not be breastfeeding.\n* Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year during the treatment period and for 6 months after the last dose of Bevacizumab. Men must refrain from donating sperm during this same period.\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Prior systemic therapy\n* Prior radiation to the region of the liver that would result in excessive doses to normal tissues due to overlap of RT fields is not allowed. Radiotherapy within 28 days and abdominal\u002Fpelvic radiotherapy within 60 days prior to initiation of study treatment are not allowed. Exception for palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment.\n* Prior selective internal radiotherapy (SIRT) or hepatic arterial Yttrium therapy, at any time.\n* Direct tumor extension into the stomach, duodenum, small bowel, or large bowel.\n* Extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) \\> 2 cm, in sum of maximal diameters (e.g. presence of one 2.4 cm metastatic lymph node or two 1.2 cm lung lesions).\n* Known fibrolamellar HCC, sarcomatoid HCC, or biphenotypic HCC.\n* History of leptomingeal disease.\n* GI bleed within 6 months prior to study registration.\n* Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses (\\\u003C30 mm from the carina) of large volume. Participants with vascular invasion of the portal or hepatic veins may be enrolled.\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    * Rash must cover \\\u003C 10% of body surface area\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n    * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n* Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to initiation of study treatment.\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment is not allowed. Abdominal surgery, abdominal interventions, or significant abdominal traumatic injury within 60 days prior to initiation of study treatment is not allowed. Participants who have not recovered from side effects of any such procedure are ineligible. Anticipation of need for a major surgical procedure during the study should reconsider enrollment.\n* History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g. \\\u003C% risk of recurrence or 5-year OS rate \\>90%), such as adequately treated carcinoma in situ of the cervix, superficial bladder cancer, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g. to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogenic stem call or solid organ transplantation.\n* Clinically significant bleeding or clotting risk requiring treatment.\n* History of hemoptysis (≥2.5 mL of bright red blood per episode) within 1 month prior to initiation of study treatment.\n* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).\n* Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose. Prophylactic anticoagulation for the patency of venous access is allowed provided the activity of the agents results in INR \\\u003C1.5 x ULN and aPTT is within normal limits within 14 days prior to study registration. Prophylactic use of low molecular-weight heparin (i.e. enoxaparin 40 mg\u002Fday) is allowed.\n* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 3 days prior to the first dose of Bevacizumab.\n* History of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment.\n* History of intestinal obstruction and\u002For clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement of routine parenteral hydration, parenteral nutrition, or tube feeding within 6 months prior to initiation of study treatment. Participants with signs\u002Fsymptoms of sub-\u002Focclusive syndrome\u002Fintestinal obstruction at the time of initial diagnosis may be enrolled if they had received definitive (surgical) treatment for the symptom resolution.\n* History of intra-abdominal inflammatory process within 6 months prior to initiation of study treatment, including but not limited to peptic ulcer disease, diverticulitis, or colitis.\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during Atezolizumab treatment or within 5 months after the last dose of Atezolizumab. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist.) are live attenuated vaccines, and are not allowed.\n* History of severe anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the Atezolizumab or Bevacizumab formulation.\n* Patients with untreated or incompletely treated varices with bleeding or high risk for bleeding. Patients must undergo an esophagogastroduodenoscopy (EGD), and all size of varices (small to large) must be assessed and treated per local standard of care prior to study registration. Patients who have undergone an EGD within 6 months prior to initiation of study treatment do not need to repeat the procedure.\n* Moderate or severe ascites.\n* Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure.\n* Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture.\n* History of hepatic encephalopathy.\n* Active co-infection of HBV and HCV. Participants with a history of HCV infection but who are negative for HCV RNA by PCR will be considered non-infected with HCV.\n* Known history of HIV infection.\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. Asymptomatic patients with CNS metastases newly detected at screening are eligible for the study after receiving radiotherapy or surgery, with no need to repeat the screening brain scan. Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:\n\n  * Measurable disease, per RECIST v1.1, must be present outside the CNS.\n  * Participant has no history of intracranial hemorrhage or spinal cord hemorrhage.\n  * Metastases are limited to the cerebellum or the supratentorial region (i.e. no metastases to the midbrain, pons, medulla, or spinal cord).\n  * No evidence of interim progression between completion of CNS-directed therapy and initiation of study treatment.\n  * Participant has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, neurosurgical resection within 28 days prior to initiation of study treatment.\n* Current or recent (within 10 days of first dose of study treatment) use of aspirin (\\>325 mg\u002Fday) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.\n* Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID) with the exception of daily Aspirin 81 mg. Occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or fever is allowed.\n* Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry.\n\n  * Symptomatic lesions (e.g. bone metastases or metastases causing nerve impingement amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.)\n  * Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g. epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Participants with indwelling catheters (e.g. PleurX®) are allowed.\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\>1.5 mmol\u002FL, calcium \\>12 mg\u002FdL, or corrected serum calcium \\> ULN)\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment.\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the initiation of study treatment.\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  * Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g. 48 hours of corticosteroids for a contrast allergy) are eligible for the study.\n  * Patients who received mineralocorticoids (e.g. fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* Inadequately controlled arterial hypertension (defined as systolic blood pressure (BP) ≥150 mmHg and\u002For diastolic blood pressure \\>100 mmHg), based on an average of ≥ 3 BP readings on ≥ 2 sessions. Anti-hypertensive therapy to achieve these parameters is allowable.\n* Prior history of hypertensive crisis or hypertensive encephalopathy.",{"count":326,"type":21},20,[83],"This research study is evaluating the safety and tolerability of the drugs atezolizumab and bevacizumab with stereotactic body radiation therapy (SBRT) for treating unresectable hepatocellular carcinoma.\n\nThis study involves the following interventions:\n\n* Atezolizumab\n* Bevacizumab\n* Stereotactic body radiation therapy (SBRT)",[25],[25],"2026-02-13",{"date":333,"type":32},"2026-02-18",{"date":335,"type":32},"2022-08-23",{"date":337,"type":21},"2032-01-31",{"name":339,"class":69},"Massachusetts General Hospital",3,{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":348,"enrollmentInfo":349,"targetDuration":4,"studyType":51,"phases":351,"briefSummary":352,"conditions":353,"keywords":354,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":4},"100619968","phase-2-a-phase-ii-trial-of-organoid-drug-sensitivity-testing-to-guide-therapy-in-unresectable-hepatocellular-carcinoma-100619968","NCT07351513","A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Hepatocellular Carcinoma","Patient-Derived Tumor Organoid Drug Sensitivity Testing to Guide Treatment Selection in Patients With Unresectable Hepatocellular Carcinoma: A Prospective, Non-randomized, Open-label, Single-Center Phase II Clinical Trial","Inclusion Criteria:\n\n1. Male or female, aged between 18 and 70 years (inclusive).\n2. Diagnosis of primary liver cancer confirmed according to the diagnostic criteria of the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer.\n3. The subject or their legal guardian understands and voluntarily signs the Informed Consent Form, and is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures as required by the protocol.\n4. Life expectancy of at least 6 months.\n5. No radiotherapy within 12 weeks prior to the first dose of the study drug.\n6. Liver function classified as Child-Pugh Class A or Class B with a score of 7.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n8. Adequate organ and bone marrow function, defined by the following laboratory values within 7 days prior to randomization (without receiving any blood transfusions, hematopoietic growth factors, albumin, or other corrective drugs within 14 days prior to the laboratory tests):\n\n   8.1. Hematological:\n   * Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL\n   * Platelet count (PLT) ≥ 75 × 10⁹\u002FL\n   * Hemoglobin (HGB) ≥ 9.0 g\u002FdL 8.2. Hepatic:\n   * Total Bilirubin (TBIL) ≤ 3 × Upper Limit of Normal (ULN)\n   * Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline Phosphatase (ALP) ≤ 5 × ULN\n   * Serum Albumin ≥ 28 g\u002FL 8.3. Renal:\n   * Serum Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CCr) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n   * Urinalysis indicates urine protein \\\u003C 2+; if baseline urinalysis shows urine protein ≥ 2+, a 24-hour urine collection must demonstrate 24-hour urine protein quantification \\\u003C 1 g.\n\n   8.4. Coagulation:\n\n   \\* International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN\n9. For women of childbearing potential (WOCBP), a negative urine or serum pregnancy test must be confirmed within 3 days prior to the first dose of study drug (Cycle 1, Day 1). If a urine test is inconclusive, a serum pregnancy test is required. WOCBP and male subjects must agree to use adequate contraception during the observation period and for at least 8 weeks after the last dose of the study drug. A woman is considered not of childbearing potential if she is postmenopausal (≥1 year without menses) or has undergone surgical sterilization (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation). Subjects (both male and female) with risk of pregnancy must use highly effective contraception (with a failure rate of \\\u003C1% per year) during the entire treatment period and for 120 days after the last dose of the study drug (or 180 days after the last dose of chemotherapy agents).\n\nExclusion Criteria:\n\n1. Uncorrectable coagulopathy or individuals with a significant bleeding tendency.\n2. Evidence of any concurrent malignant disease.\n3. Diagnosis of another malignancy within 3 years prior to the first dose, except for radically treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and\u002For carcinoma in situ that has undergone curative resection.\n4. Patients requiring long-term anticoagulant or antiplatelet therapy that cannot be discontinued.\n5. Presence of hepatic encephalopathy or refractory pleural effusion\u002Fascites requiring therapeutic intervention.\n6. Receipt of other anti-tumor or systemic therapies within 2 weeks prior to enrollment, including:\n\n   * Chinese herbal medicine with demonstrated anti-tumor properties.\n   * Chinese herbal medicine with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin), except for localized use to control pleural effusion.\n7. History of systemic treatment for active autoimmune disease or ongoing immunosuppressive therapy:\n\n   * Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment.\n   * Systemic corticosteroid therapy (excluding topical, intranasal, inhaled, or other local routes) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. The use of physiologic doses of corticosteroids (≤10 mg\u002Fday prednisone or equivalent) is permitted.\n8. Severe hepatic or renal insufficiency.\n9. Presence of any severe or uncontrolled systemic disease, including but not limited to:\n\n   * Clinically significant, poorly controlled resting ECG abnormalities (e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation).\n   * Unstable angina, congestive heart failure (New York Heart Association Class ≥ II).\n   * Myocardial infarction within 6 months prior to randomization.\n   * History of esophageal or gastric variceal bleeding within 6 months prior to enrollment.\n   * Poorly controlled hypertension (systolic blood pressure \\>140 mmHg and\u002For diastolic blood pressure \\>90 mmHg).\n   * History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year prior to the first dose, or current clinically active interstitial lung disease.\n   * Active tuberculosis.\n   * Active or uncontrolled infection requiring systemic therapy.\n   * Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.\n   * Decompensated liver disease, acute or chronic active hepatitis.\n   * Unstable or active peptic ulcer disease, or patients with gastrointestinal bleeding.\n   * Poorly controlled diabetes mellitus (fasting blood glucose \\>10 mmol\u002FL).\n   * Urinalysis indicating urine protein ≥ ++ and confirmed 24-hour urine protein quantification \\>1.0 g.\n   * Uncontrolled hypercalcemia (\\>1.5 mmol\u002FL ionized calcium, or calcium \\>12 mg\u002FdL, or corrected serum calcium \\> ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy.\n   * Non-healing wound(s) or fracture(s).\n   * Psychiatric disorder that compromises the ability to comply with the treatment protocol.\n10. Female subjects who are pregnant or breastfeeding.\n11. Assessed by the investigator as being unable or unwilling to comply with the requirements of the study protocol.\n12. Known allergy to any of the study drug(s) used in this trial.","70 Years",{"count":350,"type":21},94,[84],"This is a prospective, non-randomized, open-label, single-center phase II clinical trial. It aims to evaluate the efficacy and feasibility of using patient-derived tumor organoid drug sensitivity testing (DST) to guide personalized systemic therapy for patients with unresectable hepatocellular carcinoma (HCC). A total of 94 eligible patients will be enrolled and grouped based on patient preference into either the Organoid-Directed Therapy group or the Control group (standard therapy). Tumor tissues obtained via biopsy will be used to establish organoid cultures. Drug sensitivity testing will be performed on a pre-defined panel of approved regimens (including Atezolizumab + Bevacizumab, Sintilimab + Bevacizumab biosimilar, Apatinib + Camrelizumab, Donafenib, Lenvatinib, Tislelizumab, Sorafenib, and FOLFOX4) to identify the most effective treatment. Patients for whom organoid construction fails or valid DST results are unavailable within one month will cross over to the control group to receive standard therapy. The co-primary endpoints are Objective Response Rate (ORR) and Progression-Free Survival (PFS), both assessed according to RECIST 1.1. Secondary endpoints include Overall Survival (OS) and safety profiles. The study seeks to provide a novel, personalized treatment strategy to improve outcomes for patients with advanced, unresectable HCC.",[25],[355,356],"organoid","drug-sensitive test","2026-01-10",{"date":359,"type":32},"2026-01-20",{"date":361,"type":21},"2026-01-30",{"date":363,"type":21},"2028-12-31",{"name":365,"class":69},"Eastern Hepatobiliary Surgery Hospital",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":251,"enrollmentInfo":372,"targetDuration":4,"studyType":51,"phases":374,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":70},"100616424","downstaging-unresectable-hepatocellular-carcinoma-to-resectable-disease-with-combined-immunotherapy-and-stereotactic-beamed-radiotherapy-a-pilot-study-100616424","NCT07305428","Downstaging Unresectable Hepatocellular Carcinoma to Resectable Disease With Combined Immunotherapy and Stereotactic Beamed Radiotherapy: a Pilot Study","Inclusion Criteria:\n\n* Diagnosis of HCC is made according to American Association for the Study of Liver Diseases (AASLD) practice guideline 2010: patients with cirrhosis of any etiology and patients with chronic hepatitis B (HBV) who may not have fully developed cirrhosis, the presence of liver nodule \\>1cm and demonstrated in a single contrast enhanced dynamic imaging \\[either computed tomography (CT) or magnetic resonance imaging (MRI)\\] of intense arterial uptake and \"washout\" in portal venous and delayed phases.\n* Tumor size 5-25 cm or number of lesions ≤3 or segmental portal vein involvement\n* Age: 18-80 years old\n* Child Pugh liver function class A-B7\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n\nExclusion Criteria:\n\n* Prior invasive malignancy\n* Prior radiotherapy to the region of liver or selective internal radiotherapy\n* Severe, active co-morbidity\n* Presence of extra-hepatic metastases (M1)\n* Main portal vein or inferior vena cava (IVC) thrombosis or involvement\n* Presence of ascites or encephalopathy\n* Contraindicated of SBRT:\n\n  * Any one hepatocellular carcinoma \\> 15 cm\n  * Total maximal sum of hepatocellular carcinoma \\> 25 cm\n  * More than 3 discrete hepatic nodule\n  * Direct tumor extension into the stomach, duodenum, small bowel, large bowel, common or main branch of biliary tree",{"count":373,"type":21},30,[53],"Hepatocellular carcinoma (HCC) is one of the commonest cancers worldwide and ranks the third on the incidence of cancer-related death. There are more than 500000 new cases diagnosed annually worldwide. The incidence and prevalence of HCC are on rising trend with the majority of the disease burden is in Asia where viral hepatitis B is endemic. Surgical resection, radiofrequency ablation (RFA) and liver transplantation (LT) represent the only chance of cure for HCC patients. Despite more aggressive surgical approach has been adopted in most Asian countries, yet curative intervention remains only amendable in 30% of patients. Most patients are diagnosed with intermediate or advanced stage diseases; the long-term cure rate is only 0-10%. Hence, every effort has been made in an attempt to convert inoperable HCC into operable disease (i.e. downstaging) in order to improve the chance of survival of these patients. The current study, to our knowledge, will be the first study in the field to deploy a novel treatment strategy to deploy both immunotherapy and stereotactic beamed radiotherapy to induce tumor shrinkage rendering it become operable cancer.",[377,25],"HCC - Hepatocellular Carcinoma","2025-12-12",{"date":380,"type":32},"2025-12-26",{"date":382,"type":32},"2019-04-25",{"date":384,"type":21},"2030-12-31",{"name":386,"class":69},"The University of Hong Kong",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":394,"enrollmentInfo":395,"targetDuration":4,"studyType":51,"phases":397,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":4},"100610648","phase-2-sequential-transarterial-chemoembolization-tace-stereotactic-body-radiation-therapy-sbrt-and-immune-checkpoint-inhibitors-for-unresectable-hepatocellular-carcinoma-treated-with-donafenib-100610648","NCT07230314","Sequential Transarterial Chemoembolization (TACE), Stereotactic Body Radiation Therapy (SBRT), and Immune Checkpoint Inhibitors for Unresectable Hepatocellular Carcinoma Treated With Donafenib","Luminate Study: A Single-arm, Single-center, Open-label Clinical Study of Transarterial Chemoembolization (TACE) Plus Stereotactic Body Radiotherapy (SBRT) Combined With PD-1\u002FL1 Inhibitor and Donafenib as First-line Therapy for Unresectable Hepatocellular Carcinoma.","Inclusion Criteria:\n\n1. Age range from 18 to 75 years old (including 18 and 75), with no gender restrictions;\n2. Hepatocellular carcinoma diagnosed by histopathology, cytology or imaging;\n3. Has not received any systemic anti-tumor therapy for the current stage of the disease in the past, including surgery (excluding stent placement), radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy;\n4. CNLC staging Ib IIIa stage, cannot be surgically removed;\n5. The maximum diameter of the tumor exceeds 5cm, and the number of tumors does not exceed 3 (1-3);\n6. Can merge portal vein cancer thrombus;\n7. Has not received any systemic anti-tumor therapy for the current stage of the disease in the past, including surgery (excluding stent placement), radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy;\n8. Child Pugh score A5-B7;\n9. ECOG (Eastern Cooperative Oncology Group) Physical Status Score: 0-1 points;\n10. Expected survival period ≥ 3 months:\n11. The main organ function is good, which meets the following criteria (no blood components, cell growth factors, white blood boosting drugs, platelet boosting drugs, or anemia correcting drugs are allowed to be used within 14 days before enrollment):\n\nNeutrophils ≥ 1.5 × 109\u002FL; White blood cell count ≥ 3.0 × 109\u002FL; Platelets ≥ 100 × 109\u002FL; Hemoglobin ≥ 90g\u002FL; Serum albumin ≥ 34g\u002FL; Total bilirubin ≤ 1.5 × ULN (for patients with biliary obstruction receiving biliary drainage, it can be relaxed to\\\u003C2.5 × ULN); AST and ALT ≤ 2.5xULN (for patients with liver metastases, they can be relaxed to ≤ 5xULN); Creatinine clearance rate ≥ 60ml\u002Fmin or blood creatinine ≤ 1.5 × ULN; INR ≤ 1.5 × ULN and APTT ≤ 1.5 × ULN (for stable dose anticoagulant therapy such as low molecular weight heparin or warfarin, and INR can be screened within the expected therapeutic range of anticoagulants); Electrocardiogram: QTc ≤ 450ms (male), ≤ 470ms (female); Cardiac ultrasound: LVEF (left ventricular ejection fraction) ≥ 50%; 8) Women of childbearing age must undergo a blood pregnancy test within 7 days before enrollment, and the result must be negative. They must also be willing to use appropriate contraception methods during the trial period and for 6 months after the end of treatment. For males, surgical sterilization should be performed, or they should agree to use appropriate contraception methods during the study period and within 3 months after the end of treatment; 9) Voluntarily participate in this study and sign an informed consent form; Good compliance, agree to cooperate and receive survival follow-up;\n\nExclusion Criteria:\n\n1. Received any of the following treatments:\n\n   Previously received ICIs and\u002For HDACi treatment; Received the last anti-cancer treatment (including surgery, radiation therapy, etc.) within 4 weeks before enrollment; Received any other experimental drug\u002Fdevice treatment within 4 weeks prior to enrollment; Simultaneously enrolled in another clinical study, unless it is an observational (non interventional) clinical study or an interventional clinical study follow-up;\n2. Known patients who are allergic to the components of the investigational drug;\n3. Patients known to have central nervous system metastases;\n4. Severe gastrointestinal dysfunction (with bleeding, severe inflammation, obstruction, or diarrhea greater than grade 2);\n5. Serious infections (CTC AE\\>grade 2) occurred within the first 4 weeks of enrollment, such as severe pneumonia, bacteremia, and infection complications that require hospitalization. Symptoms and signs of infection within the first 2 weeks of enrollment require intravenous antibiotic treatment (excluding prophylactic use of antibiotics);\n6. Within the year prior to enrollment, there have been arterial\u002Fvenous thrombotic events such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism;\n7. Clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) NYHA grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n8. Patients with malignant tumors other than liver cancer prior to the first use of the investigational drug are excluded, except for malignant tumors with low-risk metastasis and mortality risk (5-year survival rate\\>90%), such as fully treated cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma;\n9. Merge active hepatitis B (HBV DNA ≥ 2000IU\u002FmL or 104 copies\u002FmL) and hepatitis C (positive for hepatitis C antibodies);\n10. People who are known to have acquired immunodeficiency syndrome (AIDS) or HIV test positive, active syphilis infection;\n11. Having a clear history of neurological or mental disorders, including epilepsy or dementia:\n12. Planned pregnancy, pregnant and lactating women; According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study midway, such as non-compliance with the protocol, having other serious illnesses (including mental illnesses) that require concomitant treatment, severe abnormal laboratory test values, family or social factors that may affect the safety of the subjects or the collection of trial data, etc;","75 Years",{"count":396,"type":21},34,[84],"This study is a single arm, single center, open label clinical trial. Recruit 34 subjects who meet the inclusion criteria and receive hepatic artery chemoembolization (TACE) and stereotactic body radiotherapy (SBRT) combined with immune checkpoint inhibitors and donafenib treatment according to the study plan. The treatment cycle and dosage can be adjusted according to the patient's tolerance. Until disease progression or intolerable toxic reactions occur. Observe the effectiveness and safety indicators during the experimental process.",[25],[401,402,403,404,405],"transarterial chemoembolization (TACE)","stereotactic body radiotherapy (SBRT)","PD-1\u002FL1 inhibitor","donafenib","first-line therapy","2025-11-14",{"date":408,"type":32},"2025-11-17",{"date":410,"type":21},"2025-11-30",{"date":412,"type":21},"2027-11-30",{"name":414,"class":69},"Jinling Hospital, China",{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":51,"phases":424,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":436},"100452181","phase-2-atezolizumab-in-combination-with-a-multi-kinase-inhibitor-for-the-treatment-of-unresectable-locally-advanced-or-metastatic-liver-cancer-100452181","NCT05168163","Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer","A Phase II Randomized Study of Atezolizumab Plus Multi-Kinase Inhibitor Versus Multi-Kinase Inhibitor Alone in Subjects With Unresectable, Advanced Hepatocellular Carcinoma Who Previously Received Atezolizumab Plus Bevacizumab","Inclusion Criteria:\n\n* Provide written informed consent =\\\u003C 28 days prior to randomization\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\n  * NOTE: During the Active Monitoring Phase of a study (i.e., active treatment and clinical follow-up), participants must be willing to return to the consenting institution for follow-up\n* Age \\>= 18 years\n* Hepatocellular carcinoma (HCC) confirmed by histological\u002Fcytological diagnosis or clinically per the American Association for the Study of Liver Diseases (AASLD) or WASL 2018 criteria\n* Locally advanced, metastatic and\u002For unresectable disease that is not amendable to curative treatment\n* Previously progressed on atezolizumab in combination with bevacizumab as first line systemic therapy for advanced disease\n\n  * NOTE: 2nd line patients only\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Child Pugh class A\n* Documented virology status of hepatitis, as confirmed by screening hepatitis B virus (HBV) and hepatitis C virus (HCV) serology tests.\n\n  * For subjects with active HBV, HBV deoxyribonucleic acid (DNA) \\\u003C 500 IU\u002FmL obtained ≤ =\\\u003C 28 days prior to randomization, and anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to randomization and willingness to continue treatment for the length of the study\n* At least one measurable untreated malignant lesion per RECIST v1.1. Subjects who previously received local therapy (e.g., ablation, percutaneous ethanol injection, trans-arterial embolization\u002Fchemo-embolization) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST v1.1\n* Consent to using archival tumor tissues, if available\n\n  * NOTE: Non-availability of tumor tissue does not exclude the subject.\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide mandatory tissue specimens for correlative research for the first 10 patients per arm (Mayo Clinic Rochester and Mayo Clinic Arizona ONLY)\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL (1500\u002FuL) without granulocyte colony-stimulating factor support (obtained =\\\u003C 28 days prior to randomization)\n* Lymphocyte count \\>= 0.5 x 10\\^9\u002FL (500\u002FuL) (obtained =\\\u003C 28 days prior to randomization)\n* Platelet count \\>= 75 x 10\\^9\u002FL (75,000\u002FuL) (obtained =\\\u003C 28 days prior to randomization)\n* Hemoglobin \\>= 90 g\u002FL (9 g\u002FdL) (obtained =\\\u003C 28 days prior to randomization)\n\n  * Subjects may be transfused to meet this criterion\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =\\\u003C 5 x upper limit of normal (ULN) (obtained =\\\u003C 28 days prior to randomization)\n* Total bilirubin =\\\u003C 3 x ULN (obtained =\\\u003C 28 days prior to randomization)\n* Serum albumin \\>= 30 g\u002FL (3.0 g\u002FdL) (obtained =\\\u003C 28 days prior to randomization)\n* For subjects not receiving therapeutic anticoagulation: international normalized ratio (INR) or partial thromboplastin time (aPTT) =\\\u003C 1.5 × ULN (obtained =\\\u003C 28 days prior to randomization)\n* Serum creatinine =\\\u003C 2 x ULN or creatinine clearance \\>= 30 mL\u002Fmin (calculated using the Cockcroft-Gault formula) (obtained =\\\u003C 28 days prior to randomization)\n* Negative pregnancy test done =\\\u003C 14 days prior to randomization, for women of childbearing potential only\n\n  * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to grade =\\\u003C 1 prior to randomization, with the exception of alopecia and peripheral sensory neuropathy.\n* Subjects of childbearing potential agree to use two forms of medically approved contraception while taking the study drug and for at least 5 months after the last dose of atezolizumab or multi-kinase inhibitor. Subjects with partners of childbearing potential agree to use condoms, even after vasectomy, to avoid potential drug exposure to partner during study drug and for 5 months following the last dose of study drug\n* Ability to take oral medications\n\nExclusion Criteria:\n\n* Known diagnosis of fibrolamellar carcinoma, sarcomatoid carcinoma or mixed hepatocellular cholangiocarcinoma\n* Prior multi-kinase inhibitor treatment for advanced disease (e.g., cabozantinib, lenvatinib, sorafenib, regorafenib)\n\n  * NOTE: Use of multi-kinase inhibitor(s) for adjuvant or as part of loco-regional therapies is allowed as long as the therapy was completed \\>= 6 months prior to randomization\n* Any of the following prior therapies:\n\n  * Major surgery =\\\u003C 4 weeks prior to randomization; Minor surgery =\\\u003C 7 days prior to randomization (e.g., simple excision, tooth extraction, insertion of central lines\u002FMediport). Subjects with clinically relevant complications from prior surgery are not eligible\n  * Any anti-cancer agent =\\\u003C 2 weeks prior to randomization\n  * Radiation therapy =\\\u003C 4 weeks (1 week for palliative radiation for bone metastases and\u002For for pain control) or radionuclide treatment (e.g., I-131 or Y-90) =\\\u003C 6 weeks prior to randomization\n* Treatment with investigational therapy =\\\u003C 28 days prior to randomization\n* Known brain or leptomeningeal metastasis\n* Known co-infection of HBV and HCV. Subjects with a history of HCV infection but who are negative for HCV ribonucleic acid (RNA) by polymerase chain reaction (PCR) will be considered non-infected with HCV\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis with the following exceptions:\n\n  * Subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study\n  * Subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study\n  * Subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are eligible for the study provided all of the following conditions are met:\n\n    * Rash must cover \\\u003C 10% of body surface area\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n    * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n\n  * NOTE: History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the subject at high risk from treatment complication\n* Treatment with a live, attenuated vaccine =\\\u003C 4 weeks prior to randomization, or anticipation of need for such a vaccine during atezolizumab treatment or =\\\u003C 5 months after the last dose of atezolizumab\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Subjects with untreated or incompletely treated esophageal\u002Fgastric varices with bleeding or high risk for bleeding. Subjects treated with adequate endoscopic therapy (according to local institutional standards) without any episodes of recurrent gastrointestinal bleeding requiring transfusion or hospitalization for \\> 28 days prior to randomization are eligible\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) =\\\u003C 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to randomization\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n\n  * Note: Prior treatment with atezolizumab is permitted\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF alpha agents) =\\\u003C 2 weeks prior to randomization, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  * Subjects who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study\n  * Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible\n* For subjects who are to receive cabozantinib: Treatment with strong inducers and\u002For strong inhibitors of CYP3A4 =\\\u003C 14 days prior to randomization, including rifampin (and its analogues) or St. John's wort. See https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers for lists of known strong inhibitors and strong inducers of CYP3A4\n* Active tuberculosis\n* Other uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders including:\n\n    * Symptomatic congestive heart failure, unstable angina, or serious cardiac arrythmias\n    * Uncontrolled hypertensions defined as sustained blood pressure (BP) \\> 150 mmHg systolic BP, or \\> 100 mmHg diastolic BP despite optimal antihypertensive treatment\n    * Stroke (including transient ischemic attack), myocardial infarction, or other ischemic event =\\\u003C 3 months prior to randomization.\n    * Unstable arrythmia\n    * Thromboembolic event =\\\u003C 3 months prior to randomization. Subjects with thromboses of portal\u002Fhepatic vasculature attributed to underlying liver disease and\u002For liver tumor are eligible.\n  * Active bacterial infection requiring systemic treatment. Subjects on prophylactic antibiotics are eligible.\n  * Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS) related illness. Subjects with known HIV but without clinical evidence of an immunocompromised state and receiving anti-retroviral therapy are eligible\n  * Prior allogenic stem cell or solid organ transplantation\n  * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n\n    * Subjects with indwelling catheters (e.g., PleurX) are allowed.\n  * Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n  * Uncontrolled tumor-related pain\n\n    * Patients requiring pain medication must be on a stable regimen at the time of randomization\n    * Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to randomization. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.\n    * Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to randomization\n* Other malignancy(ies) =\\\u003C 5 years prior to randomization except adequately treated non-melanotic skin cancer, carcinoma-in-situ of the cervix, localized prostate cancer, ductal carcinoma in situ or stage I uterine cancer\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of study medication\n* Uncontrolled hepatic encephalopathy occurring =\\\u003C 6 weeks prior to randomization NOTE: Patients with =\\\u003C grade 2 encephalopathy =\\\u003C 6 weeks prior to randomization are eligible and supportive measures such as lactulose and antibiotics are allowed",{"count":423,"type":21},122,[84],"This phase II trial tests whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic), for which the patient has received treatment in the past (previously treated). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib and lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab with cabozantinib or lenvatinib may kill more tumor cells in patients with liver cancer.",[109,128,139,143,147,156,160,164,25],"2025-09-10",{"date":429,"type":32},"2025-09-16",{"date":431,"type":32},"2022-05-27",{"date":433,"type":21},"2026-12-31",{"name":435,"class":69},"Academic and Community Cancer Research United",16,{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":445,"targetDuration":447,"studyType":22,"phases":4,"briefSummary":448,"conditions":449,"keywords":453,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":468},"100603787","the-impact-of-emotional-stress-on-immunotherapy-outcomes-in-liver-cancer-patients-a-multi-cohort-study-100603787","NCT07141056","The Impact of Emotional Stress on Immunotherapy Outcomes in Liver Cancer Patients: A Multi-Cohort Study","Impact of Emotional Stress on Immune Checkpoint Inhibitor Treatment Outcomes in Hepatocellular Carcinoma: A Multicohort Clinical Study","SOLACE","Cohort 1 (SOLACE-1):\n\nInclusion Criteria:\n\n* Age ≥ 18 years\n* Able to complete psychological questionnaires\n* Child-Pugh liver function class A\n* ECOG performance status ≤ 1\n* Signed informed consent\n* Expected survival \\> 3 months\n* Diagnosed with unresectable HCC by pathology or imaging\n* BCLC stage B or C\n* Has at least one measurable lesion (mRECIST)\n* About to receive first-line ICI treatment\n\nExclusion Criteria:\n\n* Currently taking antidepressant or anti-anxiety medications\n* Previous diagnosis of psychiatric disorders\n* Concurrent malignancy\n* Unable to complete psychological assessments\n* Previous systemic anti-tumor therapy\n* Symptomatic brain metastases\n* Child-Pugh score \\> 7\n\nCohort 2 (SOLACE-2):\n\nInclusion Criteria:\n\n* Age ≥ 18 years\n* Able to complete psychological questionnaires\n* Child-Pugh liver function class A\n* ECOG performance status ≤ 1\n* Signed informed consent\n* Expected survival \\> 3 months\n* Pathologically confirmed HCC after curative surgery\n* Pathological stage II or III (AJCC 8th edition)\n* Will start adjuvant ICI therapy within 4-6 weeks after surgery\n* Expected survival \\> 12 months\n\nExclusion Criteria:\n\n* Currently taking antidepressant or anti-anxiety medications\n* Previous diagnosis of psychiatric disorders\n* Concurrent malignancy\n* Unable to complete psychological assessments\n* Residual lesions after surgery\n* Child-Pugh score B or C\n\nCohort 3 (SOLACE-3):\n\nInclusion Criteria:\n\n* Age ≥ 18 years\n* Able to complete psychological questionnaires\n* Child-Pugh liver function class A\n* ECOG performance status ≤ 1\n* Signed informed consent\n* Expected survival \\> 3 months\n* Diagnosed with resectable HCC by pathology or imaging\n* Has at least one measurable lesion (RECIST 1.1)\n* About to receive neoadjuvant ICI treatment\n* Expected survival \\> 12 months\n\nExclusion Criteria:\n\n* Currently taking antidepressant or anti-anxiety medications\n* Previous diagnosis of psychiatric disorders\n* Severe cardiac, pulmonary, or renal dysfunction\n* Concurrent malignancy\n* Unable to complete psychological assessments\n* Previous systemic anti-tumor therapy\n* Symptomatic brain metastases\n* Child-Pugh score B or C",{"count":446,"type":21},700,"36 Months","The goal of this observational study is to learn if emotional distress affects how well liver cancer treatment works in people receiving immunotherapy. Emotional distress means feeling anxious or depressed. The study aims to answer whether having emotional distress before treatment or changes in emotional distress during treatment affect how well immunotherapy works to treat liver cancer. Researchers will compare participants with and without emotional distress to examine differences in how long the cancer stays under control, treatment response, and overall survival time. Study participants will complete mood and quality of life questionnaires, meet with mental health specialists for emotional assessments, undergo regular blood tests to measure stress hormones, have routine medical check-ups and scans to monitor their cancer status, and be followed for up to 3 years. The study includes three groups of people with liver cancer: those starting immunotherapy for cancer that cannot be removed by surgery, those receiving immunotherapy after surgery, and those receiving immunotherapy before surgery. To be eligible for participation, individuals must be 18 years or older, diagnosed with liver cancer, about to start immunotherapy treatment, and able to complete mood questionnaires.",[377,450,451,452,25],"Psychological Distress","Immune Checkpoint Inhibitors (ICIs)","Cancer, Treatment-Related",[454,455,456,457,458],"Observational Study","Hepatocellular Carcinoma (HCC)","Emotional Distress","Immune Checkpoint Inhibitors","Cancer Immunotherapy","2025-08-18",{"date":461,"type":32},"2025-08-26",{"date":463,"type":32},"2025-01-01",{"date":465,"type":21},"2027-12-31",{"name":467,"class":69},"Guilin Medical University, China",5,{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":394,"enrollmentInfo":475,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":477,"conditions":478,"keywords":479,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":70},"100537629","impact-of-splenectomy-on-the-efficacy-of-targeted-therapy-and-immunotherapy-in-unresectable-hcc-patients-with-cirrhotic-portal-hypertension-100537629","NCT06280313","Impact of Splenectomy on the Efficacy of Targeted Therapy and Immunotherapy in Unresectable HCC Patients With Cirrhotic Portal Hypertension","Inclusion Criteria:\n\n1. Patients aged 18 to 75 years (inclusive).\n2. No prior systemic antitumor treatment or meeting the criteria for splenectomy during treatment.\n3. Clinical or pathological diagnosis of hepatocellular carcinoma (HCC) that is unresectable initially or has recurred after surgery.\n4. HBV-DNA less than 1\\*10\\^5 copies\u002Fml and undergoing antiviral therapy.\n5. ECOG performance status score of 0-1, without significant organ dysfunction.\n6. Child-Pugh score of 5-7.\n7. Spleen thickness \\>4.0 cm.\n8. History of esophagogastric varices, red signs, or variceal bleeding with or without splenomegaly.\n9. Splenomegaly with WBC \\\u003C2.5 × 10\\^9\u002FL and PLT \\\u003C70 × 10\\^9\u002FL, or splenomegaly with WBC \\\u003C2.0 × 10\\^9\u002FL or PLT \\\u003C50 × 10\\^9\u002FL.\n10. Important organ functions meeting the following criteria: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3\\*ULN, total bilirubin ≤ 3\\*ULN; International normalized ratio (INR) ≤ 1.5\\*ULN; prothrombin time ≤ 1.5\\*ULN; creatinine ≤ 1.5\\*ULN.\n11. Able to undergo local treatments such as transarterial chemoembolization (TACE), hepatic artery infusion chemotherapy (HAIC), selective internal radiation therapy with yttrium-90 (SIRT), stereotactic body radiation therapy (SBRT), and ablation (including radiofrequency ablation (RFA) and microwave ablation (MWA)).\n12. Willing to provide informed consent.\n13. Expected survival time of more than 3 months.\n\nExclusion Criteria:\n\n1. History of or concurrent active malignancy (excluding malignancies that have been cured for over 5 years or in situ cancers that can be completely cured with adequate treatment).\n2. Presence of central nervous system metastasis or a history of brain metastasis.\n3. History of organ transplantation.\n4. History of surgery in the head, chest, or abdomen within the past six months.\n5. Child-Pugh class C liver function or significant ascites.\n6. Marked thrombosis in the portal venous system or extensive cancer thrombus in the main portal vein.\n7. Activated partial thromboplastin time (APTT) or prothrombin time (PT) exceeding 1.5 times the upper limit of normal (as per the normal values of the clinical trial research center), or evidence of bleeding tendency or history of bleeding within the two months prior to enrollment, regardless of severity.\n8. Ongoing active infection within 7 days after completion of systemic antibiotic therapy.\n9. Active coronary artery disease, severe\u002Funstable angina, or newly diagnosed angina or myocardial infarction within the past 12 months before enrollment.\n10. Thrombotic or embolic events within the past 12 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, or deep vein thrombosis.\n11. New York Heart Association (NYHA) class II or above congestive heart failure.\n12. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), positive syphilis serology, untreated active hepatitis (defined as HBV-DNA ≥ 10\\^5 copies\u002Fml; HCV-RNA higher than the lower limit of detection for the assay).\n13. Any active, known, or suspected autoimmune disease. Stable subjects not requiring systemic immunosuppressive therapy may be included, such as those with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, and skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, and alopecia).\n14. Interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acute pneumonia).\n15. Pregnant or lactating women or females with a positive pregnancy test prior to the first dose who have the potential for pregnancy.\n16. The investigator deems the subject inappropriate for participation in this clinical study due to any clinical or laboratory abnormalities or compliance issues.\n17. Severe psychological or mental abnormalities.\n18. Participation in another drug clinical trial within the past 4 weeks.\n19. Other reasons that the investigator considers unsuitable for enrollment.",{"count":476,"type":21},60,"Currently, the combination of targeted therapy and immunotherapy is the first-line treatment for advanced hepatocellular carcinoma (HCC). However, a subset of HCC patients with severe splenomegaly, splenic hyperfunction, and esophagogastric varices due to liver cirrhosis and portal hypertension may be unable to undergo or sustain the combination therapy, ultimately missing the optimal treatment window. Prior studies have indicated that splenectomy can significantly improve liver function and hepatic reserve in cirrhotic patients. It also addresses splenic hyperfunction and reduces the risk of bleeding from esophagogastric varices by combining splenectomy with devascularization around the cardia. Additionally, splenectomy contributes to the improvement of liver fibrosis and restoration of immune function in cirrhotic patients. This study aims to elucidate the impact of splenectomy on the efficacy of combination targeted and immunotherapy in unresectable HCC patients with cirrhotic portal hypertension, particularly those with poor liver function, significant splenic hyperfunction, and severe esophagogastric varices. The research also seeks to explore whether changes in the tumor immune microenvironment before and after splenectomy can influence the effectiveness of immunotherapy. Ultimately, the goal is to provide therapeutic opportunities for this specific patient population.",[25],[480,481,482,483],"Immunotherapy","Targeted therapy","Splenectomy","HCC","2025-08-14",{"date":486,"type":32},"2025-08-15",{"date":488,"type":32},"2024-03-15",{"date":490,"type":21},"2028-03-15",{"name":492,"class":69},"Zhiyong Huang",{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":394,"enrollmentInfo":500,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":502,"conditions":503,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":70},"100596446","haic--atezolizumab-plus-bevacizumab-in-unresectable-hcc-100596446","NCT07045558","HAIC + Atezolizumab Plus Bevacizumab in Unresectable HCC","HAIC in Combination With Atezolizumab Plus Bevacizumab as Conversion Therapy in Unresectable Hepatocellular Carcinoma: a Single-arm, Prospective Study","Inclusion Criteria:\n\n1. Patients between 18 and 75 years old, with no gender restrictions.\n2. Confirmed unresectable hepatocellular carcinoma (BCLC stage B\u002FC) by histology, cytology, or clinical diagnosis.\n3. At least one measurable lesion based on RECIST version 1.1.\n4. Child-Pugh class A or B7.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.\n6. No prior systemic therapy received, with an expected survival ≥12 weeks.\n7. Adequate organ function meeting the following criteria:\n\n   A. Hematological parameters (without blood transfusion within 14 days): Hemoglobin (Hb) ≥80 g\u002FL, White blood cell count (WBC) ≥3 × 10⁹\u002FL, Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL, Platelet count (PLT) ≥50 × 10⁹\u002FL; B. Biochemical parameters: Total bilirubin (TBIL) \\\u003C1.5 × upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C5 × ULN, Serum creatinine (Cr) ≤1.5 × ULN.\n8. Contraception requirements: Women of childbearing age must have a negative serum or urine pregnancy test (HCG) within 7 days before enrollment and agree to use effective contraceptive methods during the trial period and for 8 weeks after the last dose. Men must either have undergone surgical sterilization or agree to use appropriate contraceptive methods during the trial period and for 8 weeks after the last dose.\n9. Willingness to voluntarily participate in the study, with good compliance and commitment to follow-up.\n\nExclusion Criteria:\n\n1. Known intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma, sarcomatoid HCC, or fibrolamellar carcinoma.\n2. Concurrent autoimmune diseases, organ\u002Fhematopoietic stem cell transplantation history, or other malignancies.\n3. Impaired consciousness, inability to cooperate with treatment, or active psychiatric disorders.\n4. Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), bevacizumab, molecular targeted therapy, atezolizumab, or other PD-1\u002FPD-L1 inhibitors received before enrollment.\n5. Major surgery, chemotherapy, radiotherapy, or systemic therapy for lesions received within 1 month before enrollment.\n6. Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes (\\>10 mg\u002Fday prednisone or other equivalent drugs) within 14 days before enrollment.\n7. Severe esophageal varices or high risk of bleeding assessed by endoscopy.\n8. Evidence of decompensated liver function, including ascites, gastrointestinal bleeding, or hepatic encephalopathy.\n9. Severe organ dysfunction in major organs such as the liver, kidneys, heart, lungs, or brain.\n10. Other contraindications for interventional therapy, molecular targeted therapy, or immunotherapy.\n11. Inability to undergo scheduled follow-up or concurrent participation in other clinical trials that may interfere with this study.\n12. Other severe comorbidities deemed by the investigator to jeopardize patient safety or compromise study completion.",{"count":501,"type":21},28,"Patients with unresectable HCC will be enrolled in the cohort and will receive the combination therapy of HAIC and atezolizumab plus bevacizumab. The objective response rate is the primary endpoint, and the secondary endpoint includes disease control rate, conversion rate, pathologic complete response, major pathologic response, progression-free survival, recurrence-free survival, overall survival, quality of life, and safety.",[25],"2025-06-29",{"date":506,"type":32},"2025-07-01",{"date":508,"type":21},"2025-08-01",{"date":510,"type":21},"2028-01-31",{"name":512,"class":69},"RenJi Hospital",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":522,"conditions":523,"keywords":524,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":4},"100489983","a-multicenter-registry-study-on-stage-iii-hepatocellular-carcinoma-in-unresectable-cnlc-liver-cancer-100489983","NCT05660213","A Multicenter Registry Study on Stage III Hepatocellular Carcinoma in Unresectable CNLC Liver Cancer","A Multicenter Registry Study on the Efficacy and Safety of Different Treatment Regimens for Unresectable CNLC Liver Cancer Stage III Hepatocellular Carcinoma","Inclusion Criteria:\n\n·≥ 18 years old;\n\n* Diagnosed as unresectable hepatocellular carcinoma through histopathological and\u002For cytological examination, or meeting the clinical diagnostic criteria for hepatocellular carcinoma in the 2022 edition of the guidelines for the diagnosis and treatment of primary liver cancer;\n* CNLC liver cancer stage III;\n* Liver function Child Pugh A or B grade 7 points;\n* Has not received systematic treatment in the past;\n* Patients with active HBV infection who meet one of the following conditions can be enrolled: ① Within 28 days before enrollment, the patient's HBV DNA is less than 500 IU\u002FmL. If they have received anti HBV treatment, they need to continue their original antiviral treatment; If anti HBV treatment has not been received, it is necessary to receive anti HBV treatment throughout the entire course of medication (according to local treatment standards; for example, entecavir); ② For patients with HBV DNA\\>500 IU\u002FmL and who have not received antiviral therapy, they must receive at least 7 days of antiviral therapy (according to local treatment standards; for example, entecavir) before enrollment in this study, and are willing to continue receiving antiviral therapy during the study. Before enrollment, the serum HBV-DNA virus should be retested to decrease by more than 1 log value For patients with HBV DNA\\>500 IU\u002FmL and who have received antiviral therapy, they must receive at least 7 days of antiviral therapy (according to local treatment standards; for example, entecavir) before enrollment in this study, and are willing to continue receiving antiviral therapy during the study. Serum HBV-DNA virus levels should be retested before enrollment;\n* Active HCV infected individuals with stable disease status after treatment;\n* At least one tumor lesion available for evaluation;\n* Clear consciousness, language expression ability or reading ability, able to communicate normally, and cooperate to complete the questionnaire evaluation;\n* Voluntarily join this study and sign an informed consent form.\n\nExclusion Criteria:\n\n* Simultaneously having two or more active primary malignant tumors;\n* Portal vein cancer thrombus invades the superior mesenteric vein;\n* Received radiation therapy within the past 4 weeks;\n* Expected survival time is less than 3 months;\n* Pregnant or lactating women or those planning to conceive;\n* Coagulation dysfunction (INR\\>2.0, PT\\>16 s) or diseases with a strong likelihood of bleeding (including but not limited to esophageal and\u002For gastric variceal bleeding, active ulcers, uncontrolled hypertension);\n* Refusing to cooperate with follow-up visits;\n* Other reasons led the researchers to believe that it was not suitable to participate in this study.",{"count":521,"type":21},750,"This study is a multicenter, registered research aimed at evaluating the efficacy of different treatment regimens in the treatment of unresectable CNLC liver cancer stage III hepatocellular carcinoma",[25],[525,526,527,528,529],"Huaier granules","Unresectable hepatocellular carcinoma","curative effect","safety","Anti-PD-1\u002FPD-L1 antibody drugs","2025-05-15",{"date":532,"type":32},"2025-05-20",{"date":534,"type":21},"2025-08",{"date":536,"type":21},"2030-08",{"name":538,"class":69},"Fudan University",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":17,"minAge":546,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":51,"phases":549,"briefSummary":550,"conditions":551,"keywords":552,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":560,"locationsCount":70},"100586121","phase-1-safety-and-efficacy-of-tremelimumabdurvalumabmedi4736tace-in-unresectable-hepatocellular-carcinoma-100586121","NCT06911255","Safety and Efficacy of Tremelimumab+Durvalumab(MEDI4736)+TACE in Unresectable Hepatocellular Carcinoma","A Phase I\u002FIIa, Single-arm, Open-label, IIT for Safety and Efficacy Evaluation of Tremelimumab Plus Durvalumab(MEDI4736) in Combination With Concurrent Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n* 1\\. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n\n  2\\. Male or female, aged ≥19 years at time of study entry. 3. Diagnosed with unequivocal HCC confirmed histologically or diagnosed radiologically according to American Association for the Study of Liver Diseases practice guideline.\n\n  4\\. Barcelona clinic liver cancer (BCLC) staging intermediate (B) stage or BCLC advanced stage (C) HCC with or without minimal extrahepatic disease (single-organ metastasis, ≤5 metastatic lesions).\n\n  5\\. Must have at least 1 untreated measurable disease (untreated target lesion i.e. a viable lesion that has never been treated with locoregional treatment \\[transarterial chemoembolization {TACE}, TARE, percutaneous ethanol injection therapy, or radiofrequency ablation\\]).\n\n  6\\. Child-Pugh score 5 or 6 points (Child-Pugh class A). 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Life expectancy of ≥ 12 weeks. 9. Body weight \\>30 kg. 10. Adequate normal organ and marrow function as defined below:\n* Hemoglobin ≥9.0 g\u002FdL\n* Absolute neutrophil count (ANC) ≥1500 per mm3\n* Platelet count ≥75,000 per mm3\n* Albumin ≥2.8 g\u002FdL\n* Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). (This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with the Investigator).\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤5 x institutional ULN\n* Measured creatinine clearance (CL) \\>40 mL\u002Fmin or Calculated creatinine clearance CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24- hour urine collection for determination of creatinine clearance:\n\nMales:\n\nCreatinine CL (mL\u002Fmin) Females:\n\nCreatinine CL (mL\u002Fmin)\n\n* Weight (kg) x (140 - Age) 72 x serum creatinine (mg\u002FdL)\n* Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg\u002FdL) 11. Female patients must be either postmenopausal or, if premenopausal, must have a negative pregnancy test and agree to use 2 forms of contraception, if sexually active during their study participation.\n\nMale patients must be surgically sterile or, if sexually active and having a pre-menopausal female partner then, must be using an acceptable form of contraception.\n\nAdequate contraception allowed in this trial is as follows:\n\n* Hormonal contraceptives such as combined oral contraceptive pill\n* Intrauterine devices or the implantation of intrauterine system (IUS)\n* Blockage methods (spermicides and condoms\u002Fspermicides and vaginal diaphragm for contraception, vaginal sponges or cervical cap) • Blockage methods (spermicides and condoms\u002Fspermicides and vaginal diaphragm for contraception, vaginal sponges or cervical cap)\n* Sterilization surgery such as tubal ligation in females and vasectomy in males. 12. Evidence of postmenopausal status or negative urinary or serum pregnancy test for female premenopausal patients. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n* Women \\\u003C50 years of age would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n* Women ≥50 years of age would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n\n  13\\. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n* 1\\. Eligible for potentially curative treatment (surgical resection, radiofrequency ablation or immediate liver transplantation).\n\n  2\\. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti- Cytotoxic T-lymphocyte- associated antigen-4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune pathways, including prior randomization or treatment in a previous durvalumab and\u002For tremelimumab clinical study regardless of treatment arm assignment.\n\n  3\\. History of organ transplantation or hematopoietic stem cell transplantation.\n\n  4\\. Any other concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, papillary thyroid cancer, early gastric cancer, or other cancer for which the patient has been disease-free for at least five years.\n\n  5\\. A history of a severe contrast allergy (i.e. anaphylaxis) not controlled with premedication.\n\n  6\\. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product (IP) or interpretation of patient safety or study results.\n\n  7\\. Participation in another clinical study with an IP during the last 8 weeks or 5 half-lives of the study drug, whichever is longer, prior to screening.\n\n  8\\. Concurrent enrolment in another clinical study, unless it is an observational (non- interventional) clinical study or during the follow-up period of an interventional study.\n\n  9\\. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤1 cycle length or 14 days, whichever is longer, prior to the first dose of study drug. If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as determined by the Investigator.\n\n  10\\. Any unresolved toxicity NCI-CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.\n* Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n* Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab and\u002For tremelimumab may be included at the discretion of the Investigator.\n\n  11\\. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n\n  12\\. Prior hepatic radiation therapy including Total Body Irradiation (TBI) for HCC or other malignancy.\n\n  13\\. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.\n\n  14\\. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n* Patients with vitiligo or alopecia\n* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n* Any chronic skin condition that does not require systemic therapy\n* Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n* Patients with celiac disease controlled by diet alone 15. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent.\n\n  16\\. History of leptomeningeal carcinomatosis. 17. History of active primary immunodeficiency, including known positive tests for human immunodeficiency virus (HIV 1\u002F2 antibodies).\n\n  18\\. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), other than chronic infection of HBV or HCV. Participants with chronic HBV infection (positive hepatitis B surface antigen \\[HBsAg\\] and\u002For detectable HBV DNA) are eligible if they are receiving nucleos(t)ide analog treatment, as determined by the physician's judgment and in accordance with local practice guidelines. Those with a past or resolved HBV infection (defined as the presence of anti-hepatitis B core antibody and absence of HBsAg) are also eligible. For chronic HCV infection, participants positive for HCV antibody are eligible only if polymerase chain reaction for HCV RNA is negative.\n\n  19\\. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab and\u002For tremelimumab. The following are exceptions to this criterion:\n* Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n* Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n* Steroids as premedication for hypersensitivity reactions (e.g., Computed tomography \\[CT\\] scan premedication) 20. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.\n\nNote: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.\n\n21\\. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth from screening to 90 days after the last dose of durvalumab and\u002For tremelimumab, or 180 days after the last TACE.\n\n22\\. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n\n23\\. Judgment by the Investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.","19 Years",{"count":548,"type":21},24,[83,84],"Safety and Efficacy Evaluation of Tremelimumab Plus Durvalumab(MEDI4736) in Combination with Concurrent Transarterial Chemoembolization in Unresectable Hepatocellular carcinoma",[455,25],[553],"HCC Durvalumab","2025-05-13",{"date":556,"type":32},"2025-05-14",{"date":558,"type":32},"2025-04-18",{"date":267,"type":21},{"name":561,"class":69},"Yoon Jun Kim",{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":569,"targetDuration":4,"studyType":51,"phases":571,"briefSummary":572,"conditions":573,"keywords":574,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":70},"100586002","sirt-versus-ctace-for-unresectable-hcc-chance2506-100586002","NCT06909708","SIRT Versus cTACE for Unresectable HCC (CHANCE2506)","SIRT (Yttrium-90 Carbon Microspheres) Versus cTACE for Unresectable Hepatocellular Carcinoma: A Multicenter, Prospective, Open-label, Phase 3 Trial (CHANCE2506)","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group performance status ≤ 1;\n2. Expected survival time ≥ 3 months;\n3. Confirmed hepatocellular carcinoma based on CNLC guidelines;\n4. Without extrahepatic metastases, unresectable or refuse surgical resection;\n5. At least one well defined tumor (mRECIST 1.1);\n6. Tumor burden≤50% of the total liver volume;\n7. Child-Pugh score≤7;\n8. Adequate organ function: # Blood routine: absolute neutrophil count ≥ 1.5×10\\^9\u002FL; platelet≥75×10\\^9\u002FL; hemoglobin≥90 g\u002FL; # Liver function: total bilirubin≤2 times upper limit of normal (ULN); alanine transaminase and aspartate aminotransferase≤5.0 ULN; alkaline phosphatase≤2.5 ULN; Albumin\\>30 g\u002FL; # Renal function: Cr≤1.5 ULN; creatinine clearance≥50 mL\u002Fmin; # Coagulation function: international normalized ratio, prothrombin time and activated partial thromboplastin time were less than 1.5 ULN;\n9. Women and men of childbearing age must agree to take strict and effective contraceptive measures during the study period and within 6 m after the end of the trial.\n\nExclusion Criteria:\n\n1. With previous history of hepatic encephalopathy;\n2. Extrahepatic disease or combined with other malignant tumors;\n3. Infiltrative hepatocellular carcinoma ;\n4. With prior antitumor therapies, including liver transplantation, hepatectomy, ablation, TACE, chemotherapy, radiotherapy, targeted therapy or immunotherapy;\n5. With hepatic artery malformation and unable to undergo TACE or SIRT;\n6. Allergy to contrast agents or anesthetics\n7. With clinical manifestations of portal hypertension, moderate-severe or refractory ascites, or decompensated liver cirrhosis, or moderate-to-severe esophageal\u002Fgastric varices;\n8. With severe pulmonary insufficiency (forced expiratory volume at one second \u002F forced vital capacity\\\u003C50% or forced expiratory volume at one second \u002Fpredicting value\\\u003C50% or maximum volume per minute\\\u003C50 L\u002Fmin);\n9. The single lung radiation absorbed dose\\>30 Gy;\n10. Tumor thrombus in main portal vein or hepatic artery or hepatic vein or bile duct;\n11. Serious infections in active stage or need systematic treatment;\n12. Pregnant and lactating women;\n13. With positive results of HIV antibody test;\n14. HBV DNA or HCV RNA positive;\n15. With active syphilis or tuberculosis;\n16. 99mTc-MAA imaging (patients exclusion meet all criteria):\n\n1\\) Perfusion area covers all intrahepatic tumors (including non-target lesions) and non-perfused liver volume ≥30% of total liver volume; 2) Tumor dose ≥400 Gy for 1-2 hepatic segments; Perfused normal liver dose (PNLD): 120 Gy \\\u003C PNLD \\\u003C1000 Gy; Tumor dose ≥200 Gy (recommended ≥400 Gy) and PNLD \\\u003C120 Gy with other condition; 3) No gastrointestinal shunt , or shunt amendment by endovascular techniques (reassessment required); 4) cTACE should cover all intrahepatic lesions.",{"count":570,"type":21},108,[53],"To evaluate the efficacy and safety of yttrium-90 carbon microspheres versus cTACE in patients with unresectable hepatocellular carcinoma",[25],[483,575,576,577],"TACE","Selective internal radiation therapy","Yttrium-90","2025-04-06",{"date":580,"type":32},"2025-04-09",{"date":582,"type":32},"2025-04-03",{"date":584,"type":21},"2027-01-30",{"name":586,"class":69},"Zhongda Hospital",{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":394,"enrollmentInfo":594,"targetDuration":4,"studyType":51,"phases":595,"briefSummary":596,"conditions":597,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":70},"100584979","phase-1-icaritin-soft-capsulestaceimmunotherapytargeted-therapy-versus-taceimmunotherapytargeted-therapy-for-unresectable-hepatocellular-carcinoma-100584979","NCT06896396","Icaritin Soft Capsules+TACE+Immunotherapy+Targeted Therapy Versus TACE+Immunotherapy+Targeted Therapy for Unresectable Hepatocellular Carcinoma","Icaritin Soft Capsules and TACE Combined with Immunotherapy and Targeted Therapy Versus TACE Combined with Immunotherapy and Targeted Therapy for Unresectable Hepatocellular Carcinoma：a Prospective, Double-arm, Exploratory Study","Inclusion Criteria:\n\n* 1\\) Age range: 18-75 years old; 2) Patients diagnosed with hepatocellular carcinoma or cirrhosis through histology\u002Fcytology meet the clinical diagnostic criteria for hepatocellular carcinoma by the American Association for the Study of the Liver (AASLD). The clinical diagnostic criteria refer to the \"Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)\"; 3) Advanced primary liver cancer patients who have not received systematic treatment in the past or advanced liver cancer patients who have not received systematic treatment and have relapsed after radical resection; 4) Diseases are not suitable for radical surgery, transplantation, or ablation, but diseases are suitable for TACE treatment 5) At least one measurable lesion. Single tumor, diameter ≤ 10.0cm or multiple tumors; Number ≤ 10; The tumor burden of the lesion is less than 50%; 6) ECOG score 0-1 points; 7) Child Pugh liver function grade A; 8) Expected lifespan ≥ 3 months; 9) Blood, liver, and kidney function meet the following criteria:\n\n  1. Absolute neutrophil count ≥ 1.0 × 109\u002FL;\n  2. Platelet count ≥ 75 × 109\u002FL;\n  3. Hemoglobin concentration ≥ 90g\u002FL;\n  4. Serum albumin concentration ≥ 28g\u002FL;\n  5. Serum total bilirubin ≤ 3 x upper limit of normal (ULN);\n  6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN;\n  7. The prothrombin time extension shall not exceed ULN6s;\n  8. Creatinine\\\u003C1.5 × ULN or creatinine clearance rate (CrCl)\\>60 mL\u002Fmin (Cockcroft Gault formula); 10) If the patient is HBsAg positive, HBV-DNA should be below 2000 IU\u002Fml (10000 copies\u002Fml) during treatment; 11) Women with fertility must undergo a negative pregnancy test; 12) Acceptable contraceptive methods must be used during the research period; 13) Can understand and be willing to sign a written informed consent form; 14) Capable of swallowing and absorbing oral pills; 15) Use up to 3 types of antihypertensive drugs to fully control blood pressure, defined as systolic\u002Fdiastolic blood pressure ≤ 150\u002F90 mmHg during screening, and no change in antihypertensive treatment within the first week\u002Fweek prior to the first cycle.\n\nExclusion Criteria:\n\n* 1\\) Diffuse infiltrative lesions of the liver and brain metastases; 2) There are TACE contraindications, such as portosystemic shunt, hepatic blood flow and obvious atherosclerosis; 3) Individuals allergic to intravenous contrast agents; 4) Local treatment has been performed on existing lesions (e.g.: TACE、 Melting, particles TARE、 Hepatic artery infusion chemotherapy or radiotherapy); 5) The subject is unable to undergo enhanced liver CT or MRI scans; 6) Previous history of liver transplantation or current candidate for liver transplantation; 7) Pregnant, lactating women or participants planning to undergo contraceptive procedures within 2 years; 8) Patients with combined HIV and syphilis infections; 9) Patients with other concurrent malignant tumors or other malignant tumors within the first 5 years of enrollment; 10) Patients with severe functional impairments of the heart, kidneys, and other organs; 11) Severe clinical active infection\\>Level 2 (NCI-CTC version 5.0); 12) Mental illness patients who may affect the informed consent process; The patient is unable to take oral medication; The patient participated in clinical trials of other drugs within 12 months prior to enrollment.\n\n  13\\) Patients who have experienced esophageal or gastric variceal rupture bleeding within the past 3 months, or have unconfirmed severe varices and are at high risk; 14) Has bleeding or thrombotic disease or is undergoing thrombolytic therapy; 15) Clinical significant hemoptysis or tumor bleeding for any reason within 2 weeks prior to the first administration of the study intervention; 16) Major cardiovascular damage within the 12 months prior to the first administration of the investigational drug, such as a history of NYHA class II or higher congestive heart failure, unstable angina, myocardial infarction or cerebrovascular accident stroke, or arrhythmia related to hemodynamic instability; 17) There is clinically significant ascites during physical examination, which cannot be controlled with medication; 18) History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain Barr é syndrome, or multiple sclerosis 19) Idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, or history of idiopathic pneumonia, or evidence of active pneumonia on chest CT scan during screening 20) Known to be allergic to any component of the investigational drug formulation; 21) Other situations where the researcher deems it inappropriate to participate in the study.",{"count":476,"type":21},[83,84],"Hepatocellular carcinoma (HCC) is one of the most common malignant tumors and the leading cause of cancer-related death worldwide. Surgical resection has always been the best hope for long-term survival of patients with HCC. However, only a few patients have the opportunity to undergo surgery, and more than 70% of HCC patients have lost the opportunity of surgery at the time of diagnosis. The treatment measures for these patients are mainly transcatheter arterial chemoembolization and systemic therapy. In recent years, systemic therapies represented by targeted therapy and immunotherapy have made important progress in the field of liver cancer, improving the survival of patients with advanced unresectable HCC. Icaritin soft capsule is a monomer compound extracted, isolated, purified and enzymatically hydrolyzed from the natural medicinal plant Epimedium. It was approved for marketing on January 10, 2022 for patients with advanced first-line HCC. Icaritin soft capsules have the potential to delay TKI resistance and enhance the efficacy of PD-1 inhibitors. The aim of this study is to explore whetherIcaritin soft capsules and TACE combined with Immunotherapy and Targeted Therapy can improve the therapeutic effect of advanced HCC, ultimately prolong the survival time of patients, and provide a new treatment direction for patients with advanced HCC.",[25],"2025-03-20",{"date":600,"type":32},"2025-03-26",{"date":602,"type":21},"2025-04-01",{"date":604,"type":21},"2028-02-01",{"name":492,"class":69},{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":394,"enrollmentInfo":612,"targetDuration":614,"studyType":22,"phases":4,"briefSummary":615,"conditions":616,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":70},"100576673","prospective-collection-of-therapeutic-efficacy-and-safety-data-in-patients-with-unresectable-hepatocellular-carcinoma-100576673","NCT06788353","Prospective Collection of Therapeutic Efficacy and Safety Data in Patients with Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n1, age 18-75 years old; 2. Patients with primary unresectable liver cancer who have not received any previous treatment (in accordance with the AASLD 2018\u002FEASL 2018 Liver Cancer Diagnostic guidelines); Or patients with unresectable liver cancer who recurred for the first time after radical therapy and did not receive any postoperative adjuvant therapy; 3. There is at least one lesion in the liver that can be measured according to mRECIST criteria, and the intrahepatic lesion is a single tumor ≤10.0cm or multiple tumors (the number of tumors ≤10) and the tumor load is less than 50% (three-dimensional reconstruction of CT scan using Vitelacore software \\[version: 6.9.87.1, Canon\\], calculated as proportion of tumor volume to total liver volume) 4. Normal liver tissue volume exceeds 700ml 5, ECOG score 0-1, good general condition 6, liver function Child-Pugh grade A 7. Expected survival time ≥3 months 8. Blood, liver and kidney function meet the following conditions: a) Neutrophil count ≥1.5×109\u002FL b) Platelet count ≥60×109\u002FL c) Hemoglobin concentration ≥90g\u002FL d) Serum albumin concentration ≥30g\u002FL e) bilirubin ≤50umol\u002FL f) AST and ALT were 5 times lower than the upper limit of normal, ALP less than 4 times the upper limit of normal g) prothrombin time less than 6 seconds above the upper limit of normal h) creatinine less than 1.5 times the upper limit of normal\n\nExclusion Criteria:\n\n1. Preoperative imaging examination assessed tumor load \\>50%;\n2. Previous history of hepatic encephalopathy, refractory ascites, or esophageal and gastric varices rupture bleeding;\n3. There are contraindications for TACE treatment, such as portal shunt, isolated hepatic blood flow, and obvious atherosclerosis;\n4. Patients with extrahepatic metastasis;\n5. Allergic to intravenous contrast agents;\n6. Pregnant or lactating women or subjects who plan to have a family within two years; 7, accompanied by HIV, syphilis infection;\n\n8\\. Accompanied by other malignant tumors or had other malignant tumors within 5 years prior to enrollment; 9. Allogeneic organ transplants; 10, serious heart, kidney and other organ dysfunction; 11. Active clinical severe infection \\> Grade 2; 12. Suffering from mental illness may affect informed consent; 13, can not take oral medicine; 14. Participated in other drug clinical trials within 12 months before enrollment; 15. Active gastric or duodenal ulcer occurred 3 months before enrollment; 16. Previous history of liver or adjacent tissue radiotherapy",{"count":613,"type":21},500,"24 Months","The malignant degree of middle and advanced liver cancer is very high, and the survival prognosis of patients is very poor. TACE is currently the standard treatment for unresectable liver cancer recommended by several international authoritative guidelines. However, TACE can only extend survival from 8 months to 13 months, and the prognosis for patients with unresectable liver cancer is still not optimistic. In recent years, some studies have suggested that the combination of TACE and systemic therapy can prolong OS and PFS, but a number of prospective studies have found that the combination of TACE and targeted therapy can not improve the prognosis of unresectable liver cancer. However, TACE as a non-radical treatment is difficult to achieve complete tumor necrosis, so it is still unknown which treatment combination can best improve the prognosis. This trial is an observational clinical trial to explore the efficacy and safety of TACE combined targeting\u002Fimmunotherapy for unresectable hepatocellular carcinoma. Clinical data of patients with unresectable liver cancer treated in our hospital from March 2023 to March 2025 are intended to be collected to evaluate the efficacy and safety of TACE combined with different systems for unresectable liver cancer.",[258,617,25],"Systemic Therapy","2025-01-19",{"date":620,"type":32},"2025-01-23",{"date":622,"type":32},"2023-03-01",{"date":624,"type":21},"2027-03-01",{"name":626,"class":69},"Sun Yat-sen University",{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":251,"enrollmentInfo":634,"targetDuration":4,"studyType":51,"phases":636,"briefSummary":637,"conditions":638,"keywords":639,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":70},"100561730","tace-with-thermosensitive-nanogel-versus-embosphere-for-hcc-100561730","NCT06593964","TACE With Thermosensitive Nanogel Versus Embosphere for HCC","Safety and Efficacy of TACE With Thermosensitive Nanogel Embolic Agent Versus Embosphere for Hepatocellular Carcinoma: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial","Inclusion Criteria:\n\n1. Chinese Liver Cancer Staging Scheme, stage IIb-Illa, as well as those with stage Ia-Ila HCC, unsuitable or unwilling to undergo surgical resection, transplantation, or ablation;\n2. Liver function status: Child-Pugh A or B\n3. Eastern Cooperative Oncology Group score: 0-2 points;\n4. With at least one measurable, unembolized liver tumor lesion (1-10 cm) ;\n5. Willing to participate in this trial and sign the informed consent.\n\nExclusion Criteria:\n\n1. The target lesion has been embolized before or require combined with other treatment(s);\n2. Diffuse or with extrahepatic metastasis;\n3. Coagulation dysfunction (PT prolonged beyond the upper limit of normal for 3 seconds);\n4. Severe renal dysfunctions (creatinine clearance rate \\\u003C30 ml\u002Fmin);\n5. Severe liver dysfunctions (alanine aminotransferase or aspartate aminotransferase exceeding the upper limit of normal by 5 times);\n6. Main portal vein was completely occluded and no collateral blood supply was established;\n7. With uncorrectable arteriovenous fistula or portal vein fistula;\n8. Severe cachexia or hepatic encephalopathy;\n9. With active infection;\n10. Significant reductions in white blood cells or platelets (white blood cells\\\u003C3.0x109\u002FL, platelets\\\u003C50x109\u002FL) that cannot be corrected;\n11. Pregnant or lactating women;\n12. Difficulty in selective catheterization;\n13. With the severe risk of non-target embolization;\n14. Severely allergic to contrast agents or the embolic materials;\n15. Participating in ongoing trial;\n16. Unsuitable judged by the investigator.",{"count":635,"type":21},188,[53],"To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC.",[25],[640,258],"Hepatocellular carcinoma","2024-09-09",{"date":643,"type":32},"2024-09-19",{"date":645,"type":21},"2024-09-10",{"date":647,"type":21},"2026-04-30",{"name":586,"class":69},{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":4,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":348,"enrollmentInfo":656,"targetDuration":4,"studyType":51,"phases":658,"briefSummary":660,"conditions":661,"keywords":662,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":664,"lastUpdatePostDateStruct":665,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":4},"100554263","phase-4-donafenib-combined-with-immunotherapy-and-local-therapy-for-unresectable-hepatocellular-carcinoma-that-has-failed-in-previous-therapy-100554263","NCT06496815","Donafenib Combined With Immunotherapy and Local Therapy for Unresectable Hepatocellular Carcinoma That Has Failed in Previous Therapy","The Efficacy and Safety of Donafenib Combined With Immunotherapy and Local Therapy for Unresectable Hepatocellular Carcinoma That Has Failed in Previous Therapy","Inclusion Criteria:\n\n1. Voluntarily participate in this study, sign the informed consent form, and be aged between 18 and 70 years old.\n2. Have at least one measurable lesion.\n3. Clinically and pathologically diagnosed with hepatocellular carcinoma and not suitable for surgical resection.\n4. Child-Pugh liver function classification: Class A\u002FClass B.\n5. Have previously received targeted therapy (excluding donafenib) in combination or not in combination with immunotherapy, locoregional therapy (transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC)), and have clear tumor progression assessed by two clinicians using the RECIST criteria.\n6. If infected with hepatitis B virus (HBV), such as positive for HBsAg, HBV-DNA must be tested, and HBV-DNA must be less than 500 IU\u002FmL; for patients with HBV-DNA greater than 500 IU\u002FmL, at least one week of antiviral treatment is required before randomization (only nucleoside analogs such as entecavir, tenofovir disoproxil fumarate, and tenofovir alafenamide tablets are allowed), and the viral copy number should be reduced by more than 10 times compared to before treatment. For HBV infected individuals, antiviral treatment must be received throughout the study period. Patients who are positive for hepatitis C virus (HCV)-RNA must receive antiviral treatment according to the treatment guidelines.\n7. Serum bilirubin should be ≤2.0 times the upper limit of normal (ULN); this condition does not apply to patients with confirmed Gilbert's syndrome. Any clinically significant biliary obstruction must be resolved before enrollment in the study.\n8. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be ≤2.5 times the ULN. For patients with liver metastases, ALT and AST should be ≤5 times the ULN.\n\nExclusion Criteria:\n\n1. Have an active autoimmune disease or a history of autoimmune disease that may recur (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism).\n2. Use of immunosuppressants or systemic corticosteroid therapy for the purpose of immunosuppression within 2 weeks prior to treatment (dose \\>10mg\u002Fday prednisone or other equivalent efficacy corticosteroids).\n3. Patients with congenital or acquired immune function deficiency (such as HIV-infected individuals).\n4. Have a history of other primary malignant tumors, except for the following situations: malignant tumors treated with curative intent, known to be inactive for ≥5 years prior to the first study intervention and with a low potential risk of recurrence; basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or malignant melanoma in situ that has been treated with potentially curative intent; or in situ cancer that has been adequately treated with no evidence of disease.\n5. Known allergy to any study drug or excipients.\n6. Participation in other drug clinical studies within the past 4 weeks.\n7. Pregnant or lactating women.",{"count":657,"type":21},32,[659],"PHASE4","The goal of this clinical trial is to learn if donafenib combined with or without immunotherapy and local therapy works to treat unresectable hepatocellular carcinoma that has failed in previous therapy.\n\nIt will also learn about the safety of donafenib combined with immunotherapy and local therapy.\n\nThe main questions it aims to answer are:\n\nThe Objective Response Rate (mRecist） and Progression-Free Survival of the participants treated by donafenib combined with immunotherapy and local therapy.\n\nThe disease control rate and overall survival of the participants treated by donafenib combined with immunotherapy and local therapy.\n\nThe safety of donafenib combined with immunotherapy and local therapy in the participants.\n\nParticipants will:\n\nReplace the original targeted drug with donafenib (0.2g bid), while continuing immunotherapy and local therapy as previous therapy (if have).\n\nThe observation period was 1 year.",[25],[663],"Donafenib","2024-07-04",{"date":666,"type":32},"2024-07-11",{"date":668,"type":21},"2024-08-01",{"date":670,"type":21},"2027-07-30",{"name":672,"class":69},"Tongji Hospital",{"id":674,"slug":675,"hasResults":12,"nctId":676,"briefTitle":677,"officialTitle":678,"acronym":4,"eligibilityCriteria":679,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":680,"targetDuration":4,"studyType":51,"phases":682,"briefSummary":683,"conditions":684,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":685,"lastUpdatePostDateStruct":686,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":691,"locationsCount":70},"100543759","phase-2-anti-pd-1pd-l1-combined-with-anti-angiogenic-agents-as-first-line-treatment-for-unresectable-hcc-100543759","NCT06360042","Anti-PD-1\u002FPD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC","Anti-PD-1\u002FPD-L1 Combined With Anti-angiogenic Agents as First-line Therapy for Unresectable Hepatocellular Carcinoma: a Multicenter, Randomized, Open-label Trial","Inclusion Criteria:\n\n* Locally advanced or metastatic and\u002For unresectable Hepatocellular Carcinoma (HCC)\n* No prior systemic therapy for HCC. Previous use of herbal therapies\u002Ftraditional Chinese medicines with anti-cancer activity included in the label is allowed.\n* BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and\u002For local therapy\n* At least one measurable lesion per RECIST v1.1\n* ECOG Performance Status of 0 or 1\n* Child-Pugh class of A5 to B7\n* Adequate organ function\n\nExclusion Criteria:\n\n* Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously\n* Moderate-to-severe ascites with clinical symptoms\n* History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage\n* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment\n* Known genetic or acquired hemorrhage or thrombotic tendency\n* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment\n* Hypertension that can not be well controlled through antihypertensive drugs Factors to affect oral administration\n* History of hepatic encephalopathy\n* Previous or current presence of metastasis to central nervous system",{"count":681,"type":21},111,[84],"This is a multicenter, randomized, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib (cohort 1), or Adebrelimab plus Bevacizumab (cohort 2), or Camrelizumab plus Apatinib (cohort 3) as first-line treatment of unresectable HCC.",[25],"2024-04-19",{"date":687,"type":32},"2024-04-22",{"date":689,"type":32},"2024-01-01",{"date":191,"type":21},{"name":692,"class":69},"Peking University Cancer Hospital & Institute",{"id":694,"slug":695,"hasResults":12,"nctId":696,"briefTitle":697,"officialTitle":698,"acronym":4,"eligibilityCriteria":699,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":700,"targetDuration":4,"studyType":51,"phases":702,"briefSummary":703,"conditions":704,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":706,"lastUpdatePostDateStruct":707,"startDateStruct":709,"completionDateStruct":711,"leadSponsor":713,"locationsCount":70},"100509745","phase-2-phase-2-study-of-sbrt-plus-tislelizumab-and-regorafenib-in-unresectable-or-oligometastatic-hcc-100509745","NCT05917431","Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCC","Phase 2 Study of Stereotactic Body Radiation Therapy Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic Hepatocellular Carcinoma","Inclusion Criteria:\n\n* age ≥ 18 years\n* Eastern Cooperative Oncology Group performance status of 0-1\n* clinical or pathological diagnosis of HCC\n* with unresectable locally advanced or oligometastatic HCC (metastatic lesions ≤ 5, metastatic organs ≤ 3, may involve extrahepatic lymph nodes or distant organs apart from brain)\n* at least one measurable lesion according to mRECIST criteria\n* all lesions could be included in radiation target volume\n* Child-Pugh A or B (7 scores) liver function\n* patients are allowed to receive systemic therapy previously other than tislelizumab plus regorafenib\n* adequate hematological and renal function\n* life expectancy ≥ 3 months；\n* willing to participate in the study and give written informed consent\n\nExclusion Criteria:\n\n* a history of liver transplantation\n* with severe cirrhosis complications, including a history of esophagogastric variceal bleeding, hepatic encephalopathy, and massive ascites\n* with active autoimmune diseases or a history of autoimmune disease\n* with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)\n* allergic to the ingredient of tislelizumab or regorafenib\n* with recurrent lesions treated with radiotherapy previously\n* prescribed radiation does could not be delivered due to dose limits to organs at risk (OAR)\n* intolerable to radiation or systemic treatment because of cardiac insufficiency, uncontrolled high blood pressure\n* a history of other malignancies, except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix",{"count":701,"type":21},39,[84],"The goal of this phase 2 prospective clinical trial is to learn about the efficacy and safety of stereotactic body radiation therapy (SBRT) plus immunotherapy and targeted therapy in patients with unresectable or oligometastatic hepatocellular carcinoma (HCC).\n\nThe main question to answer is: Whether combing SBRT with immunotherapy and targeted therapy could prolong PFS. Participants will receive SBRT to all visible lesions and concurrent systemic immunotherapy and targeted therapy.",[25,705],"Oligometastatic Disease","2023-06-15",{"date":708,"type":32},"2023-06-23",{"date":710,"type":21},"2023-06",{"date":712,"type":21},"2026-12-30",{"name":692,"class":69}]