[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatocellular-carcinoma-non-resectable\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatocellular-carcinoma-non-resectable":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,44,67,94,123,145,169,199,218,247,270,298,323,347,368,395,416,439,460,482,505,531,553,575,595],{"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":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100601418","yttrium-90-radiation-segmentectomy-for-hepatocellular-carcinoma-100601418",false,"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%).","ALL","22 Years",{"count":20,"type":21},64,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Hepatocellular Carcinoma","Unresectable Hepatocellular Carcinoma","Hepatocellular Cancer","Hepatocellular Carcinoma Non-resectable","NOT_YET_RECRUITING","2026-06-23",{"date":34,"type":35},"2026-06-26","ACTUAL",{"date":37,"type":21},"2026-10-01",{"date":39,"type":21},"2029-03-31",{"name":41,"class":42},"University of California, San Francisco","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":63,"leadSponsor":65,"locationsCount":43},"100439024","adjuvant-stereotactic-body-radiation-therapy-after-trans-arterial-chemoembolization-in-hepatocellular-carcinoma-100439024","NCT04996914","Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma","ASTrH","Inclusion Criteria:\n\n* HCC (diagnosis: histological or radiological)\n* Age: 18-80\n* Number of lesions 1-3 lesions\n* Size of the lesion (or sum of 2-3 lesions) ≥ 4 cm\n* Sufficient non-tumorous liver volume (≥ 800 cm3)\n* Child Pugh Score: A5-6 or B7-8\n* BCLC A or B\n* Patient is illegible or refused surgical resection or orthotopic liver transplant\n* Blood work (within 2 weeks before registration):\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm³)\n* Platelets ≥50,000 cells\u002Fmm³\n* AST (and ALT) \\\u003C 5 times ULN\n* Serum creatinine ≤ ULN or creatinine clearance ≥ 50 mL\u002Fmin\n\nExclusion Criteria:\n\n* Evidence of extrahepatic disease (lymph node or distant metastases)\n* Evidence of macroscopic vascular invasion\n* Evidence of an arterio-portal or arterio-venous fistulas\n* History of previous malignancy\n* Previous SIRT\n* Previous Sorafenib in the last 8 weeks\n* Pregnant and lactating females","18 Years","80 Years",{"count":54,"type":21},30,[24],"The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection.",[30],"RECRUITING","2026-05-05",{"date":61,"type":35},"2026-05-11",{"date":59,"type":35},{"date":64,"type":21},"2029-05-05",{"name":66,"class":42},"RWTH Aachen University",{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100602329","phase-2-evaluation-of-sirt-followed-by-immunotherapy-for-treatment-of-hepatocellular-carcinoma-with-portal-vein-thrombosis-100602329","NCT07122089","Evaluation of SIRT Followed by Immunotherapy for Treatment of Hepatocellular Carcinoma With Portal Vein Thrombosis","A Multicenter Open-label, Prospective Study to Evaluate the Efficacy and Safety of SIRT Using Yttrium-90 Glass Microspheres Followed by Durvalumab and Tremelimumab for Treatment of Hepatocellular Carcinoma With Portal Vein Thrombosis","IOSPHERE","Inclusion Criteria:\n\n1. Age ≥ 18,\n2. ECOG Performance Status 0-1,\n3. Histologically proven HCC or noninvasive HCC diagnosis according to LiRADS criteria,\n4. HCC with Portal vein involvement (PVT), segmental, sectorial or lobar, evaluated by diagnostic imaging (CT scan or MRI),\n5. At least one measurable lesion≥ 10mm using mRECIST criteria evaluated by diagnostic imaging,\n6. Tumor involvement \\\u003C50% of the liver,\n7. Hepatic reserve after SIRT ≥ 30% (i.e. hepatic parenchyma not treated with SIRT) evaluated by diagnostic imaging\n8. No cirrhosis or Compensated cirrhosis (Child Pugh A, ALBI score 1 or 2),\n9. SIRT indication confirmed by a multidisciplinary team meeting (i.e. patient not a candidate for liver resection, thermal ablation, or transplantation at the time of study),\n10. Registration with a social security scheme,\n11. Written and informed consent of the patient.\n\nExclusion Criteria:\n\n1. Patient with main PVT (partial or complete),\n2. Extrahepatic metastases (patients with EHS), except hilum node \\\u003C 2 cm,\n3. Previous episode of ascites and\u002For presence of ascites, even if only seen on imaging without clinical detection (except minimum blade only peri-hepatic),\n4. Previous episode of hepatic encephalopathy and\u002For hepatic encephalopathy presence at study entry and\u002For episodes of encephalopathy (Grade ≥2) within 6 months prior to study inclusion,\n5. Pulmonary insufficiency (defined by an arterial oxygen pressure (PaO2) of \\\u003C60 mmHg, or oxygen saturation (SaO2) of \\\u003C90% (Roussos \\& Koutsoukou, 2003) or clinically evident chronic obstructive pulmonary disease (COPD),\n6. Medical history of radiation pneumonitis or recent pneumonitis, regardless of causality,\n7. Previous HCC therapies:\n\n   1. Any prior systemic treatment for HCC;\n   2. More than 2 prior TACE (or embolization), in the area to be treated;\n   3. Liver resection or ablation \\\u003C6 months from end of previous treatment to TheraSphere administration;\n   4. Liver ablation \\\u003C3 months from end of previous treatment to TheraSphere administration.\n8. Prior exposure to immune mediated therapy for HCC or other disease, such as other anti-PD-1, anti-PDL-1, anti-PDL-2, anti-CTLA-4, antibodies, etc.\n9. Previous liver radiation (external beam radiation therapy (EBRT) or peptide receptor radionuclide therapy (PRRT) or SIRT\n10. Inadequate hematological, hepatic and renal functions:\n\n    1. Hemoglobin \\\u003C8,5 g\u002Fdl;\n    2. Granulocytes \\\u003C1500\u002Fmm3;\n    3. Platelets \\\u003C 50 000 \u002Fmm3;\n    4. Bilirubin level ≥35 umol\u002Fl;\n    5. Albumin \\\u003C28g\u002FL;\n    6. Transaminases \\> 5 UNL;\n    7. Creatinine \\> 1,5 UNL;\n    8. INR\\>2 (or TP \\\u003C60%) without anti-coagulation.\n11. Any contraindication to angiography or selective visceral catheterization,\n12. History of any organ allograft, including bone marrow allo and autograft,\n13. History of active primary\u002Facquired immunodeficiency, that makes patients unsuitable for additional immunotherapy in this study (per investigator),\n14. Active or prior documented autoimmune or inflammatory disorders (including but not limited to inflammatory bowel disease \\[e.g. ulcerative colitis or Crohn's disease\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis\\]). The following are exceptions to this criterion:\n\n    1. Patients with vitiligo or alopecia;\n    2. Patients with hypothyroidism (e.g. following Hashimoto's syndrome) stable on hormone replacement therapy;\n    3. Any chronic skin condition that does not require systemic therapy;\n    4. Patients with celiac disease controlled by diet alone.\n15. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra-articular injection),\n16. In the case of background systemic corticosteroid use, doses of prednisone or its equivalent \\>10 mg\u002Fday,\n17. Need for premedication of hypersensitivity reactions with Steroids (e.g. CT scan premedication),\n18. History of gastrointestinal bleeding within 42 days prior to study inclusion, active GI bleeding and any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents (e.g. closure device). Patients with known varices that have not bled or which have been clinically addressed can enter the study. No endoscopic exploration is required before study inclusion,\n19. Presence of biliary stent or sphincterotomy within one year prior to study inclusion,\n20. History of malignancy, other than HCC, within two years, except the condition is one of the following:\n\n    1. Adequately treated carcinoma in situ of the cervix, early squamous cell carcinoma or basal cell carcinoma of the skin, localized prostate cancer, breast ductal carcinoma in situ, or low-grade endometrial carcinoma with no myometrial invasion;\n    2. Localized prostate cancer under active surveillance;\n    3. Other cancer when there is a negligible risk of recurrence or progression or death (5-year OS rate \\> 90%).\n21. Major surgical procedure (as defined by the Investigator) within 42 days prior to study inclusion,\n22. A history of severe allergy or intolerance to contrast agents, narcotics, sedatives, or atropine that cannot be managed medically,\n23. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients that cannot be managed medically,\n24. Active infection, including:\n\n    1. Tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice),\n    2. HBV\\* and Hep D co-infection,\n    3. Human immunodeficiency virus\\*\\* (HIV 1\u002F2 antibodies) plus HCV or HBV\\* co-infection.\n\n       * Patients with active HBV infection or HCV infection must be managed according to local standard of care. Patients must show evidence of viral disease stabilization prior to inclusion.\n\n         * Patients with Human Immunodeficiency Virus (HIV) infection are eligible, provided the HIV infection is well controlled with no current or previous AIDS-related complications and CD4+ T-cell (CD4+) counts ≥ 350 cells\u002FµL\n25. Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab and\u002For tremelimumab. Note: patients, if enrolled, should not receive live vaccine whilst receiving durvalumab and\u002For tremelimumab and up to 30 days after the last dose of durvalumab and\u002For tremelimumab,\n26. Participation in another clinical trial in the 4 weeks prior to enrollment, unless it is an observational study or a 4-week no-treatment follow-up phase of an interventional study,\n27. Female patients who are pregnant (a negative serum pregnancy test is mandatory for inclusion) or breastfeeding and who do not want to stop breastfeeding. Male or female patients of reproductive potential who are not willing to employ any effective birth control method from screening and for at least 3 months post the last dose of study treatment (durvalumab ± tremelimumab and\u002For TheraSphere), whichever is later,\n28. Unstable chronic disease or evidence of any disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere, durvalumab and tremelimumab treatment as deemed by the site principal investigator,\n29. Patients who are not able to follow the TheraSphere, durvalumab or tremelimumab treatment requirements,\n30. Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8 and persons admitted to a health or social establishment for purposes other than research, including:\n\n    1. Persons receiving psychiatric treatment;\n    2. Persons admitted to a health or social establishment for purposes other than research;\n    3. Person of full age under curatorship;\n    4. Adult subject to a mandate for future protection, a family authorization, or a guardianship measure.\n\nAngiograhy and dosimetry exclusion criteria:\n\n1. Cone Beam CT (CBCT) or Technetium-99m Macro Aggregated Albumin (99mTc-MAA) hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques,\n2. 99mTc-MAA hepatic arterial perfusion scintigraphy shows poor tumor targeting and\u002For a poor portal vein thrombosis (PVT) targeting (99mTc-MAA uptake ≤ normal liver uptake),\n3. The dosimetry endpoints cannot be reached (refer to the supplement A \"TheraSphere Treatment Planning, Dosimetry Guidance document\"),\n4. Shunting of blood to the lungs that could result in delivery of \\>30 Gy to the lungs in a single treatment, or \\>50 Gy cumulative dose to the lungs in case of multiple TheraSphere treatments, as seen on 99mTc-MAA hepatic arterial perfusion scintigraphy.",{"count":76,"type":21},80,[78],"PHASE2","Hepatocellular carcinoma (HCC) is the most common primary liver cancer, being the third leading cause of cancer-related death worldwide, with approximately 745 000 deaths reported annually.\n\nFor advanced patients, including patients with tumoral portal vein thrombosis (PVT), most treatment guidelines recommend systemic therapy, either combination immunotherapy (IO) or combination of immunotherapy and anti-angiogenic treatment for first line option.\n\nResults for PVT patients are provided in one trial with a median overall survival of 14.2 months with IO underlying the necessity to improve treatment of PVT patients. Two recent other phase 3 trials also reported positive results for different IO regimen.\n\nSelective internal radiation therapy (SIRT) using yttrium-90 (90Y)-loaded glass microspheres (TheraSphereTM) can be used for patients with early stage to locally advanced HCC including PVT patients without extrahepatic spread (EHS). TheraSphereTM is recognized and is reimbursed in France for PVT patients without EHS, since 2019.Several retrospective studies have shown promising results for PVT patients.\n\nNowadays use of SIRT in locally advanced HCC is regaining interest based on the results of the randomized DOSISPHERE-01 study including non-operable patients, about 70% with PVT. This randomized Phase II trial using 90Y-loaded microspheres sought was noted the effectiveness of 90Y-loaded microspheres using a personalized dosimetry approach versus a standard dosimetry approach.\n\nThe use of a systemic treatment as IO after a locoregional treatment with the strong local debulking effect of SIRT is logical and of interest. Indeed, the most frequent pattern of progression after SIRT is recurrence in an untreated area, including untreated liver or EHS. Patients are then usually referred to IO.\n\nSuch kind of therapeutic approach, using SIRT followed by IO has already been evaluated in a phase 2 study using nivolumab after 90Y loaded resin microspheres with promising efficacy without safety deterioration.\n\nThe aim of this study is to evaluate SIRT followed by IO used according to their current indications in advanced HCC patient with PVT patients and without EHS.",[30],[82,83,84],"Hepatocellular carcinoma","Immunotherapy","Selective internal radiation therapy","2026-04-29",{"date":59,"type":35},{"date":88,"type":35},"2026-02-25",{"date":90,"type":21},"2030-01-02",{"name":92,"class":42},"Center Eugene Marquis",6,{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":107,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":43},"100526309","phase-2-atezolizumab-and-bevacizumab-with-proton-radiotherapy-for-unresectable-hepatocellular-carcinoma-100526309","NCT06133062","Atezolizumab and Bevacizumab With Proton Radiotherapy for Unresectable Hepatocellular Carcinoma","Investigation of Antitumor Immune Response in Patients With Unresectable Hepatocellular Carcinoma Undergoing Proton Radiotherapy Combined With Atezolizumab and Bevacizumab","ProtonAB","Inclusion Criteria:\n\n* Participants must have diagnosis of HCC that is deemed unsuitable for surgical resection or transplant. Participants may have multiple lesions with a total maximal tumor dimension of \\\u003C 20 cm, and no one lesion \\> 15 cm. Diagnosis should be confirmed by at least 1 criterion listed below:\n\n  * Histologically or cytologically proven diagnosis of HCC.\n  * Typical arterial enhancement and delayed washout on multiphasic CT or MRI.\n* Age ≥18 years at the time of signing informed consent document.\n* ECOG performance status 0-1.\n* Barcelona Clinic Liver Cancer (BCLC) stages Intermediate (B) or Advanced (C).\n* Child-Pugh score 5-6 liver function within 28 days of study registration.\n* Documented virology status of hepatitis B virus (HBV), as confirmed by screening HBV serology test.\n* Documented virology status of hepatitis C virus (HCV), as confirmed by screening HCV serology test.\n* Ability to understand and the willingness to sign a written informed consent document\n* Adequate bone marrow, liver, and renal function within 4 weeks before study registration\n\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm3\n  * Platelet count ≥ 50,000\u002FμL\n  * Total bilirubin \\\u003C 2.5 mg\u002FdL\n  * Serum albumin \\>2.8 g\u002FdL\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN)\n  * Prothrombin time ≤ 6 seconds prolonged\n  * Serum creatinine ≤ 1.5 mg\u002FdL\n\nExclusion Criteria:\n\n* Prior invasive malignancy unless disease free for a minimum of 2 years\n* Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields\n* Prior selective internal radiotherapy\u002Fhepatic arterial yttrium therapy, at any time\n* Untreated active hepatitis B or hepatitis C\n* Moderate to severe or intractable ascites\n* Presence of distant metastases that cannot be encompassed by proton radiotherapy\n* Untreated or incomplete treated esophageal or gastric varices\n* Severe, active co-morbidity, defined as follows:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months prior to registration\n  * Myocardial infarction within the last 6 months prior to study entry\n  * Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry\n  * A bleeding episode within 6 months prior to study entry due to any cause.\n  * Thrombolytic therapy within 28 days prior to study entry.\n  * Known bleeding or clotting disorder.\n  * Uncontrolled psychotic disorder\n* Pregnancy or women of childbearing potential and men who are sexually active and not willing\u002Fable to use medically acceptable forms of contraception\n* Prior solid organ transplantation.\n* Prior or active autoimmune disease (AID) including autoimmune hepatitis, inflammatory bowel disease, myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, and multiple sclerosis.\n* Prior or active thrombotic or bleeding disorders, hemoptysis, cerebral vascular accident, significant cardiac disease (ischemic or congestive heart failure), or gastrointestinal perforation.\n* Inability to treat all sites of disease by proton radiotherapy (such as extrahepatic metastases or massive liver tumors whereby the liver constraints \\[ULV\u002FSLV \\>40%\\] cannot be met for covering all sites of liver tumors using proton radiotherapy.)\n* Known HIV infection.",{"count":103,"type":21},45,[78],"Atezolizumab (anti-programmed death-ligand 1; anti-PD-L1) in conjunction with bevacizumab (anti-vascular endothelial growth factor; anti-VEGF) has become the established standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). Despite an improved objective response rate (ORR) of 27%, the majority of patients face HCC progression and liver failure \\[Finn et al., N Engl J Med 2020\\]. Developing a new combined treatment strategy to overcome resistance to anti-PD-L1 and anti-VEGF is essential to improve patient outcomes.\n\nRadiation treatment (RT) is notably effective in managing localized solid tumors and is a fundamental component of unresectable HCC treatment. Recent retrospective cohorts have demonstrated that proton RT targeting all hepatic tumors, along with PD-L1\u002Fprogrammed death-1 (PD-1) blockade, enhances ORR and progression-free survival for unresectable HCC patients, displaying a favorable safety profile (Su et al., Am J Cancer Res. 2022). Our preclinical study (Hsieh et al., Sci Immunol 2022) showcased that RT combined with PD-L1\u002FPD-1 blockade stimulates immunogenic cell death and antigen cross-presentation in murine tumor models, promoting systemic antitumor T cell responses. Nonetheless, it is crucial to verify whether the combined therapy of proton RT, atezolizumab, and bevacizumab triggers synergistic antitumor effects and systemic immune activation in clinical trials for unresectable HCC. This phase II non-randomized trial aims to prospectively evaluate therapeutic efficacy, safety, and immunological responses in patients with unresectable HCC treated with atezolizumab\u002Fbevacizumab combined with proton radiotherapy.",[30],[108,109,110,111,112,113],"Proton radiotherapy","HCC","PD-L1","VEGF","Atezolizumab","Bevacizumab","2026-03-18",{"date":116,"type":35},"2026-03-20",{"date":118,"type":35},"2023-11-16",{"date":120,"type":21},"2030-09-30",{"name":122,"class":42},"Chang Gung Memorial Hospital",{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":17,"minAge":129,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":43},"100621238","a-retrospective-study-of-safety-and-efficacy-of-locoregional-therapies-combined-with-anti-vegftkis-and-immune-checkpoint-inhibitors-for-all-comers-of-intention-to-treat-patients-with-unresectable-hepatocellular-carcinoma-100621238","NCT07368023","A Retrospective Study of Safety and Efficacy of Locoregional Therapies Combined With Anti-VEGF\u002FTKIs and Immune Checkpoint Inhibitors for All Comers of Intention-to-treat Patients With Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Aged 16 years or older.\n* Clinical and\u002For pathological diagnosis of hepatocellular carcinoma (HCC). China Liver Cancer (CNLC) stage I, II, or IIIA.\n* Assessed by a multidisciplinary team (MDT) as having initially unresectable HCC.\n\nExclusion Criteria:\n\n* Presence of extrahepatic metastasis.\n* Presence of Cheng's type IV portal vein tumor thrombus (PVTT).\n* Presence of Cheng's type II or III inferior vena cava tumor thrombus (IVCTT).","16 Years",{"count":131,"type":21},300,"OBSERVATIONAL","This is a single-center, retrospective cohort study aiming to evaluate the safety and efficacy of a combined conversion therapy strategy for patients with initially unresectable hepatocellular carcinoma (HCC).The primary objective is to assess the outcomes of intention-to-treat (ITT) patients who received multidisciplinary conversion therapy. This therapy combines locoregional treatments (LRT, such as TACE or radiotherapy) with systemic therapy (anti-VEGF\u002Ftyrosine kinase inhibitors and immune checkpoint inhibitors) with the goal of down-staging tumors to allow for subsequent curative resection.\n\nThe study plans to enroll 300 subjects. The exposure group will include approximately 100 patients with initially unresectable HCC who received the combined conversion therapy between January 2018 and December 2024. A control group of about 200 patients with initially resectable HCC who underwent direct radical surgery during the same period will be used for comparison. Data will be collected retrospectively from hospital electronic medical records and the HCC clinical database, with follow-up until December 2025.",[27,30],"2026-01-20",{"date":137,"type":35},"2026-01-26",{"date":139,"type":21},"2026-01-25",{"date":141,"type":21},"2026-05-31",{"name":143,"class":144},"Ningbo Medical Center Lihuili Hospital","OTHER_GOV",{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":43},"100607768","phase-2-adebrelimab--apatinib-in-advanced-hcc-post-systemic-therapy-100607768","NCT07192848","Adebrelimab + Apatinib in Advanced HCC Post-Systemic Therapy","Efficacy and Safety of Adebrelimab Plus Apatinib in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Systemic Therapy: A Single-arm, Phase II Study","Inclusion Criteria:\n\n1. Patients voluntarily participate in this study and sign the informed consent form;\n2. Aged ≥ 18 years (calculated as of the date of signing the informed consent form), male or female;\n3. Pathologically or clinically confirmed hepatocellular carcinoma (HCC);\n4. Have previously received at least one or more lines of systemic therapy (targeted therapy with or without immunotherapy);\n5. Barcelona Clinic Liver Cancer (BCLC) stage B or C, unsuitable for surgery or local treatment, or progressed after surgery and\u002For local treatment;\n6. Local treatment (including but not limited to surgery, radiotherapy, hepatic artery embolization, transcatheter arterial chemoembolization \\[TACE\\], hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) must have been completed at least 4 weeks before the baseline imaging scan (palliative radiotherapy requires only 2 weeks), and toxic reactions caused by local treatment (except alopecia) must have recovered to ≤ Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0);\n7. Presence of measurable lesions meeting the modified Response Evaluation Criteria in Solid Tumors (mRECIST) on baseline imaging;\n8. Child-Pugh liver function class A;\n9. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-1;\n10. Expected survival time \\> 3 months;\n11. Basic normal function of major organs, without severe abnormalities in blood, heart, lung, liver, kidney, bone marrow, or immunodeficiency diseases, meeting the protocol requirements:\n\n    1. Blood routine examination: (except hemoglobin; no blood transfusion, no use of granulocyte colony-stimulating factor \\[G-CSF\\] within 14 days before screening, and no corrective treatment within 7 days) i. Hemoglobin ≥ 90 g\u002FL; ii. Neutrophil count ≥ 1.5×10\\^9\u002FL; iii. Platelet count ≥ 50×10\\^9\u002FL;\n    2. Biochemical examination: (no albumin transfusion within 14 days) i. Serum albumin ≥ 29 g\u002FL; ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); iii. Total bilirubin (TBIL) ≤ 1.5×ULN; iv. Creatinine (Cr) ≤ 1.5×ULN or creatinine clearance \\> 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula as follows): For males: Creatinine clearance = ((140 - age) × weight) \u002F (72 × serum Cr) For females: Creatinine clearance = ((140 - age) × weight) \u002F (72 × serum Cr) × 0.85 (Weight unit: kg; Serum Cr unit: mg\u002FmL) v. Urinary protein \\\u003C 2+; if urinary protein ≥ 2+, a 24-hour urinary protein quantification can be performed, and patients with 24-hour urinary protein quantification \\\u003C 1.0 g are eligible for enrollment;\n    3. Coagulation function: Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN (patients receiving stable-dose anticoagulant therapy such as low-molecular-weight heparin or warfarin with INR within the expected therapeutic range of anticoagulants can be screened);\n    4. Thyroid-stimulating hormone (TSH) ≤ ULN; if abnormal, triiodothyronine (T3) and thyroxine (T4) levels should be examined, and patients with normal T3 and T4 levels are eligible;\n12. Patients with active hepatitis B virus (HBV) infection who are willing to receive full-course antiviral therapy during the study (according to local standard treatment, such as entecavir) may be eligible for enrollment based on the doctor's judgment of individual patient conditions under viral load monitoring;\n13. Patients with positive hepatitis C virus (HCV) ribonucleic acid (RNA) must receive antiviral therapy according to local standard treatment guidelines, and liver function elevation must be within CTCAE Grade 1;\n14. Female patients of childbearing potential: Must agree to abstain from heterosexual intercourse or use reliable and effective contraception from the signing of the informed consent form until at least 120 days after the last dose of the study drug. Additionally, serum human chorionic gonadotropin (HCG) must be negative within 7 days before the start of study treatment; and must be non-lactating. A female patient is considered to have childbearing potential if she has menstruated, has not reached postmenopausal status (amenorrhea for ≥ 12 consecutive months with no other identified causes except menopause), and has not undergone sterilization (such as hysterectomy, bilateral salpingectomy, or bilateral oophorectomy);\n15. Male patients whose partners are women of childbearing potential must agree to abstain from heterosexual intercourse or use reliable and effective contraception from the signing of the informed consent form until at least 120 days after the last dose of the study drug. Male subjects must also agree not to donate sperm during the same period. Male subjects whose partners are pregnant must use condoms and do not need to adopt other contraceptive methods.\n\nExclusion Criteria:\n\n1. Previously received PD-L1 immunotherapy or apatinib targeted therapy;\n2. No clear tumor-feeding artery identifiable by angiography;\n3. Known cholangiocellular carcinoma, sarcomatoid HCC, mixed-cell carcinoma, or fibrolamellar carcinoma; having other active malignant tumors (except HCC) within 5 years or concurrently. Locally cured tumors such as basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast are eligible for enrollment;\n4. Allergic to the investigational drugs;\n5. Complicated with other malignant tumors, except for the following cases: malignant tumors treated with curative therapy, with no known active disease for ≥ 5 years before the first study intervention and low potential risk of recurrence; basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, or lentigo maligna with potentially radical treatment; or carcinoma in situ with adequate treatment and no evidence of disease;\n6. A history of hepatic encephalopathy;\n7. Received other investigational drug treatments within 28 days or 5 half-lives (whichever is longer) before the start of study treatment;\n8. Complicated with severe infection;\n9. Any evidence of disease as judged by the investigator (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, active hemorrhagic diseases, active infections, active interstitial lung disease\u002Fpulmonary inflammation, severe chronic gastrointestinal diseases related to diarrhea, mental illness\u002Fsocial conditions) or a history of allogeneic organ transplantation that the investigator considers makes the subject unfit to participate in the study or affects compliance with the study protocol;\n10. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel diseases \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[excluding diverticulosis\\], systemic lupus erythematosus, sarcoidosis syndrome, Wegener's syndrome \\[granulomatosis with polyangiitis\\], Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis, etc.);\n11. Known positive HIV test (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical assessment may include clinical history, physical examination, and imaging findings, or tuberculosis testing according to local practices).",{"count":153,"type":21},47,[78],"Patients with locally advanced unresectable or metastatic hepatocellular carcinoma (HCC) who progressed after prior systemic therapy (targeted ± immunotherapy) are enrolled. Primary endpoint: objective response rate (ORR). Planned enrollment: 47 subjects. Eligible patients receive adebrelimab + apatinib.\n\nAfter informed consent and screening, treatment starts: Adebrelimab 1200mg IV on D1, Q3W; apatinib 250mg oral QD, continuous. 21-day cycle. Treatment continues until intolerable toxicity, consent withdrawal, RECIST v1.1-proven progression (may continue if clinically beneficial), or protocol-specified criteria (whichever first).\n\nSafety follow-up on D1 of each cycle; imaging every 2 cycles (6-8 weeks) for efficacy. Post-treatment: continued safety and survival follow-up.",[30],[158,159,27],"Adebrelimab","Apatinib","2025-09-17",{"date":162,"type":35},"2025-09-25",{"date":164,"type":21},"2025-09",{"date":166,"type":21},"2027-06",{"name":168,"class":42},"Song Peng",{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":43},"100585578","phase-2-lenvatinib-sintilimab-and-deb-tace-withwithout-haic-for-hcc-7-cm-with-pvtt-100585578","NCT06904183","Lenvatinib, Sintilimab, and DEB-TACE With\u002FWithout HAIC for HCC >7 cm With PVTT","Lenvatinib, Sintilimab, and Drug-Eluting Beads Transarterial Chemoembolization With or Without Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma >7 cm With Portal Vein Tumor Thrombus: A Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n* a confirmed diagnosis of HCC\n* the largest intrahepatic lesion \\>7 cm\n* presence of PVTT on imaging\n* tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment\n* Eastern Cooperative Oncology Group performance status ≤1\n* Child-Pugh class A\u002FB\n* adequate hematologic and organ function, with leukocyte count\\>3.0×10\\^9\u002FL, neutrophil count\\>1.5×10\\^9\u002FL, platelet count≥75×10\\^9\u002FL, hemoglobin 85 g\u002FL, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal; prothrombin time prolongation ≤4 seconds\n* life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* accompanied with vena cava tumor thrombus\n* central nervous system involvement\n* previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy\n* organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment\n* history of other malignancies\n* uncontrollable infection\n* history of HIV\n* history of organ or cells transplantation","75 Years",{"count":178,"type":21},320,[78],"This study is conducted to evaluate the efficacy and safety of lenvatinib plus sintilimab, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (LEN+SIN+DEB-TACE+HAIC) versus lenvatinib plus sintilimab and DEB-TACE (LEN+SIN+DEB-TACE) for large hepatocellular carcinoma (\\> 7cm) with portal vein tumor thrombosis (PVTT).",[30],[183,184,185,186,187,188,189],"hepatocellular carcinoma","lenvatinib","transarterial chemoembolization","drug-eluting bead","hepatic arterial infusion chemotherapy","portal vein tumor thrombosis","sintilimab","2025-04-28",{"date":192,"type":35},"2025-04-29",{"date":194,"type":35},"2025-04-01",{"date":196,"type":21},"2030-03-31",{"name":198,"class":42},"Second Affiliated Hospital of Guangzhou Medical University",{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":176,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":216,"leadSponsor":217,"locationsCount":43},"100585579","phase-2-lenvatinib-plus-sirt-vs-lenvatinib-in-tace-refractory-hcc-100585579","NCT06904196","Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC","Lenvatinib Combined With Yttrium-90 Selective Internal Radiation Therapy (SIRT) Versus Lenvatinib Alone in TACE-Refractory Hepatocellular Carcinoma: A Prospective Non-Randomized Controlled Study","Inclusion Criteria:\n\n* Pathologically confirmed or clinically diagnosed HCC\n* Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021)\n* Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included\n* At least one measurable intrahepatic target lesion\n* Child-Pugh class A\u002FB\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Tumor extent \\\u003C70% liver occupation\n* Candidates for SIRT must be confirmed suitable for SIRT after evaluation (including SPECT\u002FCT evaluation after arterial perfusion with 99Tc-MAA)\n* Adequate organ and hematologic function with platelet count ≥50×10\\^9\u002FL, leukocyte \\>3.0×10\\^9\u002FL, Neutrophil count ≥1.5×10\\^9\u002FL, haemoglobin ≥85 g\u002FL, ALT and AST≤5×ULN, albumin ≥28 g\u002FL, total bilirubin ≤3× ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds\n* Life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* Extrahepatic metastasis\n* Tumor thrombus involving main portal vein or both the first left and right branches of portal vein\n* Vena cava invasion\n* Patients who received prior hepatic arterial infusion chemotherapy (HAIC), radiotherapy, or systemic therapy, for HCC\n* History of organ and cell transplantation\n* History of esophageal or gastric variceal bleeding\n* History of hepatic encephalopathy\n* History of other malignancies\n* Human immunodeficiency virus infection",{"count":207,"type":21},78,[78],"This study is conducted to evaluate the efficacy and safety of lenvatinib plus SIRT (LEN+SIRT) compared with lenvatinib (LEN) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).",[30],[183,212,213],"Lenvatinib","Yttrium-90",{"date":192,"type":35},{"date":194,"type":35},{"date":39,"type":21},{"name":198,"class":42},{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":230,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":43},"100436606","phase-2-evaluation-of-treatment-predictors-reflecting-beta-catenin-activation-in-hepatocellular-carcinoma-100436606","NCT04965454","Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma","Clinical Trial of Biomarkers for Predicting Immunotherapy Response in Hepatocellular Carcinoma","ExTRACT-HCC","Inclusion Criteria:\n\n* Age 18 years or older (no upper limit of age)\n* Hepatocellular carcinoma diagnosis made histologically or radiographically in accordance to National Comprehensive Cancer Network guidelines (3.2019 version or higher)\n* Does not qualify for surgical resection or locoregional therapy alone or has disease that has progressed after surgical resection and\u002For locoregional therapy\n* Has measurable disease defined as at least one tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 on CT\u002FMRI completed within past 6 weeks of eligibility screening\n* Under the care of a licensed medical oncologist\n* Life expectancy \\> 6 months\n* Deemed eligible for treatment with an immune checkpoint inhibitor agent based on the treating medical oncologist's assessment of previous treatment failure, clinical\u002Fperformance\u002Fvirology status, and liver\u002Frenal\u002Fhematologic function.\n* Child-Pugh score of 9 or less\n* Creatinine clearance ≥ 40 mL\u002Fmin, measured or calculated using the Cockcroft-Gault formula\n* ALT and AST ≤7x upper limit of normal\n* Total bilirubin ≤4 mg\u002FdL\n* Albumin ≥2.8 g\u002FdL\n\nExclusion Criteria:\n\n* Weight \\> 500 lbs (PET\u002FCT limit)\n* Pregnant or lactating female (those of child-bearing potential must be re-screened within 7 days prior to PET\u002FCT imaging)\n* Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure\n* Concurrent treatment with a non-targeted therapeutic agent. Concurrent enrollment in an ICI-treatment trial and combination ICI treatment are allowed.",{"count":76,"type":21},[78],"This prospective clinical trial will evaluate PET\u002FCT and genomic liquid biopsy based biomarkers as predictors of clinical therapeutic response to immune-checkpoint inhibitor (ICI) therapy for patients with inoperable hepatocellular carcinoma (HCC). The primary objective of this diagnostic trial is to assess the accuracy of pre-treatment fluorine-18 (18F-) fluorocholine (FCH) PET\u002FCT for predicting a lack of objective response (LOR) after 16 weeks of ICI therapy.",[30],[183,231,232,233,234,235,236,237,238],"immunotherapy","positron emission tomography","mutation profiling","liquid biopsy","personalized medicine","diagnostic","fluorocholine","immune checkpoint inhibitor",{"date":240,"type":35},"2025-05-01",{"date":242,"type":35},"2022-03-28",{"date":244,"type":21},"2028-06-30",{"name":246,"class":42},"Queen's Medical Center",{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":256,"conditions":257,"keywords":258,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":269},"100494116","combined-haic-tkianti-vegf-and-icis-as-conversion-therapy-for-unresectable-hepatocellular-carcinoma-100494116","NCT05713994","Combined HAIC, TKI\u002FAnti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma","Combined Hepatic Arterial Infusion Chemotherapy, Tyrosine Kinase Inhibitor\u002F Anti-VEGF Antibody, and Anti-PD-1\u002F PD-L1 Antibody as Conversion Therapy for Unresectable Hepatocellular Carcinoma","CCGLC-001","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Diagnosis of HCC is according to the American Association for the Study of Liver Diseases or European Association for the Study of the Liver guidelines of HCC management;\n3. at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or mRESIST criteria;\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n5. Hepatocellular carcinoma (HCC) was assessed as not suitable for radical resection, liver transplant, or ablation treatment after the assessment of a multidisciplinary team because either: (1) R0 resection was not feasible; (2) remnant liver volume was less than 30% in patients who did not have cirrhosis or 40% in patients with cirrhosis, or the results of an indocyanine green test were higher than 15%; (3) patients had Barcelona Clinic Liver Cancer (BCLC) stage B and beyond Up-to-seven criteria; or (4) patients had BCLC stage C.\n6. Portal vein involvement (Chen's groups A and B, or Cheng's type I-III) is allowed: Chen's group A1 or Cheng's type I, tumor thrombus is involved in segmental or sectoral branches of the portal vein or above; Chen's group A2 or Cheng's type II, involvement of the first branch of portal vein; Chen's group B or Cheng's type III, involvement of the main portal vein.\n7. Hepatic vein invasion (VV1 to VV2) were allowed. Patients with tumor thrombus in inferior vena cava (VV3 type, Sakamoto type 1) can be included; However, patients with inferior vena cava tumor thrombus exceeding the diaphragmatic plane (Sakamoto type II) and reaching the right atrium (Sakamoto type III) cannot be included in the study;\n8. Patients with extrahepatic oligometastasis is allowed: extrahepatic oligometastasis was defined as up to three metastatic lesions in up to two organs with the largest diameter of 3 cm\n9. Child-Pugh liver function class A-B7\n10. No prior transplantation, TACE, or radioembolization to the liver was allowed. Prior locoregional therapies, such as surgical resection, radiotherapy, radiofrequency ablation, percutaneous ethanol injection or cryoablation, are allowed if the disease have progressed since prior treatment. Local therapy must have been completed at least 4 weeks prior to the baseline scan.\n11. Adequate organ and marrow function, as defined below:\n\n(1) Hemoglobin≥80 g\u002FL; (2) Absolute neutrophil count ≥1.5 ×10\\^9\u002FL; (3) Platelet count ≥50 ×10\\^9\u002FL; (4) Total bilirubin \\\u003C 51 μmol\u002FL; (5) Alanine transaminase (ALT) and aminotransferase (AST)≤5×ULN; (6) Albumin ≥28 g\u002FL; (7) INR ≤1.6; (8) Serum creatinine \\\u003C 110 μmol\u002FL.\n\nExclusion Criteria:\n\n1. Prior invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, lobular or ductal carcinoma in situ of the breast that has been surgically cured\n2. Severe, active and uncontrolled co-morbidity including but not limited to:\n\n(1) Persistent or activity (except the HBV and HCV) infection; (2) symptoms of congestive heart failure and uncontrolled diabetes; (3) uncontrolled hypertension, systolic pressure≥160 mmHg or diastolic pressure≥100 mmHg despite anti-hypertension medications≤28 days before randomization or first dose of drug; (4) unstable angina; (5) uncontrolled arrhythmias; (6) active ILD; (7) severe chronic GI disease accompanied by diarrhea; (8) compliance with requirements may limit the research, resulted in significant increase risk of AE or influence Subjects provided psychiatric\u002Fsocial problem status on their ability to provide written informed consent; (9) A history of active primary immunodeficiency or human immunodeficiency virus; (10) Active or previous records of autoimmune disease or inflammatory diseases, including inflammatory bowel disease (e.g., colitis or Crohn's disease\\], diverticulitis, except \\[diverticulosis\\], systemic lupus erythematosus (SLE), sarcoidosis syndrome or Wegener syndrome (e.g., granulomatous vasculitis, gray's disease, rheumatoid arthritis, the pituitary gland inflammation and uveitis\\]); (11) A history of hepatic decompensation, including refractory ascites, gastrointestinal bleeding, or hepatic encephalopathy.\n\n3\\. Known to produce allergic or hypersensitive reactions to any study drug or any excipient thereof.\n\n4\\. Significant clinical gastrointestinal bleeding or a potential risk of bleeding was identified by the investigator during the 30 days prior to study entry.\n\n5\\. Tumors of the central nervous system, including metastatic brain tumors. 6. Pregnant women or breast-feeding patients. 7. Has received anti-tumor system therapy for HCC. Non-anti-tumor purpose combined hormone therapy (e.g., hormone replacement therapy) is excluded.\n\n8\\. Is currently using, or has used an immunosuppressive drug within 14 days prior to the first dose of the investigational drug. This standard has the following exceptions: (1) intranasal, inhaled, topical or topical steroids. (e.g., intraarticular); (2) Systemic corticosteroid therapy not exceeding 10 mg\u002F day of prednisone; (3) prophylactic use of steroids for hypersensitivity. (e.g., CT scan pretherapy medication).\n\n9\\. A live attenuated vaccine was administered within 30 days prior to the first administration of the study drug. Note: If enrolled, patients shall not receive live attenuated vaccine within 30 days of receiving study drug therapy and after the last administration of study drug.\n\n10\\. Extrahepatic vascular involvement or thrombosis: superior mesenteric vein (Cheng's type IV), or with inferior vena cava tumor thrombus exceeding the diaphragmatic plane (Sakamoto type II) or reaching the right atrium (Sakamoto type III) cannot be included in the study.",{"count":131,"type":21},"This study is conducted to evaluate the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of hepatic artery infusion chemotherapy (HAIC), tyrosine kinase inhibitor\u002F anti-VEGF antibody, and anti-PD-1\u002F PD-L1 antibody for advanced hepatocellular carcinoma which initially unsuitable for the radical therapy, including resection, transplantation, or ablation. Factors are collected in preoperative routine blood examination, preoperative radiological imaging and pathological examination.",[30],[259,27],"Liver Neoplasms","2025-03-20",{"date":262,"type":35},"2025-03-25",{"date":264,"type":35},"2020-05-19",{"date":266,"type":21},"2025-12-30",{"name":268,"class":42},"Ze-yang Ding, MD",2,{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":17,"minAge":278,"maxAge":279,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":287,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":43},"100515493","phase-2-atezolizumab-plus-bevacizumab-alone-or-combined-with-external-beam-radiotherapy-for-hcc-with-macrovascular-invasion-100515493","NCT05992220","Atezolizumab Plus Bevacizumab Alone or Combined with External Beam Radiotherapy for HCC with Macrovascular Invasion","A Randomized, Multicenter, Open-Label, Phase II Trial of Atezolizumab Plus Bevacizumab Alone or Combined with External Beam RadioTherapy for HepatoCellular Carcinoma with Macrovascular Invasion (ALERT-HCC)","ALERT-HCC","Inclusion Criteria:\n\n* Older than 19 years of age, lower than 80 years of age\n* Child-Pugh class A hepatic function\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1\n* Patients with HCC \\[diagnosed according to AASLD guidelines\\] invading the intrahepatic vascular system\n* No prior systemic therapy for HCC\n* At least one measurable HCC lesion with ≥ 1cm diameter\n* Adequate hematologic and organ function\n\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Absolute neutrophil count ≥ 1,000 \u002Fmm3\n  * Platelet ≥ 50,000\u002F mm3 without transfusion\n* Total bilirubin ≤ 2.5 mg\u002FdL\n\nExclusion Criteria:\n\n* Treatment history of prior systemic treatment of HCC\n* Liver transplant recipients\n* Patients with peptic ulcer, untreated or incompletely treated varices with bleeding or high-risk for bleeding\n* Any serious illness (e.g., active infection or inflammatory condition) or uncontrolled severe medical comorbidity\n* A history of treated malignancy (other than HCC) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years\n* Abdominal\u002Fpelvic radiotherapy within 28 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment","20 Years","79 Years",{"count":281,"type":21},138,[78],"The recent global IMbrave150 study evaluated the combination of atezolizumab and bevacizumab versus sorafenib in 501 patients with advanced or metastatic Hepatocellular Carcinoma (HCC). The median overall survival (OS) was notably better in the atezolizumab\u002Fbevacizumab group. However, for HCC patients with intrahepatic macrovascular invasion (MVI), the prognosis remains poor, indicating a significant unmet need in this group.\n\nExternal Beam Radiotherapy (EBRT) has shown promising results in treating HCC with MVI, especially when used in combination with trans-arterial chemoembolization (TACE). It has been reported that radiotherapy may make tumor cells more susceptible to immune-mediated therapy, potentially enhancing the effects of atezolizumab and bevacizumab.\n\nThus, this study aims to investigate the efficacy and safety of atezolizumab\u002Fbevacizumab alone versus atezolizumab\u002Fbevacizumab in combination with EBRT in HCC patients with macrovascular invasion.",[27,29,30,285,286],"Hepatocellular Carcinoma Stage IV","Liver Cancer",[288],"HCC; vascular invasion; portal vein tumor thrombosis; BCLC stage C","2025-02-19",{"date":291,"type":35},"2025-02-21",{"date":293,"type":35},"2022-10-22",{"date":295,"type":21},"2026-03",{"name":297,"class":42},"Asan Medical Center",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":176,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":310,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":43},"100546614","phase-2-deb-taceralox-haic-vs-deb-tace-for-large-hcc-100546614","NCT06397235","DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC","DEB-TACE in Combination With or Without RALOX-based HAIC for Unresectable Large Hepatocellular Carcinoma: A Randomized, Controlled Trial","Inclusion Criteria:\n\n* HCC confirmed by histology\u002Fcytology or diagnosed clinically.\n* At least one measurable intrahepatic target lesion.\n* The largest tumor size \\> 7 cm.\n* Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment.\n* Child-Pugh score 5-7.\n* ECOG performance status ≤ 1.\n* Adequate organ and hematologic function with platelet count ≥75×10\\^9\u002FL, leukocyte \\>3.0×10\\^9\u002FL, Neutrophil count ≥1.5×10\\^9\u002FL, ASL and AST≤5×ULN, creatinine clearance≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds.\n\nExclusion Criteria:\n\n* Macrovascular invasion or extrahepatic metastasis.\n* Diffuse HCC.\n* Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.\n* Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, systemic therapy.\n* Organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment.\n* History of other malignancies.\n* Uncontrollable infection.\n* History of HIV.\n* Gastrointestinal bleeding within 30 days, or other bleeding\\> CTCAE grade 3.\n* History of organ or cells transplantation.\n* Pregnant or lactating patients.",{"count":306,"type":21},130,[78],"This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) combined with hepatic artery infusion chemotherapy (HAIC) with oxaliplatin and raltitrexed (RALOX-HAIC) versus DEB-TACE alone for unresectable large hepatocellular carcinoma (HCC).",[30],[27,185,311,312,313,314],"drug-eluting beads","hepatic artery infusion chemotherapy","oxaliplatin","raltitrexe","2025-02-18",{"date":317,"type":35},"2025-02-20",{"date":319,"type":35},"2024-05-01",{"date":321,"type":21},"2028-04-30",{"name":198,"class":42},{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":176,"enrollmentInfo":330,"targetDuration":4,"studyType":22,"phases":332,"briefSummary":333,"conditions":334,"keywords":336,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":269},"100570437","phase-2-y-90-sirt-for-unresectable-hcc-larger-than-7cm-100570437","NCT06707233","Y-90 SIRT for Unresectable HCC Larger Than 7cm","Y-90 Selective Internal Radiation Therapy for Unresectable Hepatocellular Carcinoma Larger Than 7cm: a Prospective, Single Arm Trial","Inclusion Criteria:\n\n* Pathologically confirmed or clinically diagnosed HCC\n* Unresectable HCC as assessed by a team of surgeons\n* The largest tumor size \\> 7 cm\n* Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment\n* At least one measurable intrahepatic target lesion\n* Appropriate for SIRT treatment after evaluation (including SPECT\u002FCT evaluation after arterial perfusion with 99Tc-MAA)\n* Child-Pugh score ≤ 7\n* ECOG PS ≤ 1\n* Adequate organ and hematologic function with platelet count ≥75×10\\^9\u002FL, leukocyte \\>3.0×10\\^9\u002FL, Neutrophil count ≥1.5×10\\^9\u002FL, haemoglobin ≥85 g\u002FL, ALT and AST≤5×ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds\n* life expectancy of at least 6 months\n\nExclusion Criteria:\n\n* Macrovascular invasion or extrahepatic metastasis\n* Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy\n* Organ (heart and kidneys) dysfunction\n* History of other malignancies\n* Uncontrollable infection\n* History of organ or cells transplantation\n* History of HIV\n* Pregnant or lactating patients",{"count":331,"type":21},33,[78],"This is a phase II clinical study to evaluate the efficacy and safety of SIRT in patients with HCC greater than 7 cm. After enrollment, patients received yttrium-90 selective internal radiation therapy. The primary endpoint of the study is objective reponse rate (ORR) as assessed by mRECIST. Secondary endpoints were: objective response rate (ORR) as assessed by RECIST 1.1, disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and safety (incidence and severity of adverse events).",[335],"Hepatocellular Carcinoma Non-Resectable",[27,337,338],"yttrium-90","selective internal radiation therapy","2025-01-26",{"date":341,"type":35},"2025-01-28",{"date":343,"type":35},"2024-12-01",{"date":345,"type":21},"2027-11-30",{"name":198,"class":42},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":176,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":358,"conditions":359,"keywords":360,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":43},"100553923","phase-3-lenvatinib-plus-deb-tace-and-haic-vs-lenvatinib-plus-deb-tace-for-large-hcc-with-pvtt-100553923","NCT06492395","Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT","A Multicentre, Randomised Controlled Study of Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy With FOLFOX Regimen Versus Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization for Hepatocellular Carcinoma Larger Than 7 cm With Portal Vein Tumor Thrombosis","Inclusion Criteria:\n\n* a confirmed diagnosis of HCC\n* the largest intrahepatic lesion \\>7 cm\n* presence of PVTT on imaging\n* tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment\n* Eastern Cooperative Oncology Group performance status ≤1\n* Child-Pugh class A\u002FB\n* adequate hematologic and organ function, with leukocyte count\\>3.0×10\\^9\u002FL, neutrophil count\\>1.5×10\\^9\u002FL, platelet count≥75×10\\^9\u002FL, hemoglobin 85 g\u002FL, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal\n* life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* Diffuse HCC\n* accompanied with vena cava tumor thrombus\n* central nervous system involvement\n* previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy\n* organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment\n* history of other malignancies\n* uncontrollable infection\n* history of HIV\n* history of organ or cells transplantation\n* prothrombin time prolongation \\>4 s",{"count":355,"type":21},178,[357],"PHASE3","This study is conducted to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+DEB-TACE) for large hepatocellular carcinoma (\\> 7cm) with portal vein tumor thrombosis (PVTT).",[30],[183,184,185,186,187,188],{"date":362,"type":35},"2025-01-29",{"date":364,"type":35},"2024-08-01",{"date":366,"type":21},"2027-07-31",{"name":198,"class":42},{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":22,"phases":378,"briefSummary":379,"conditions":380,"keywords":381,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":394},"100509300","biopearl-microspheres-loaded-with-doxorubicin-for-the-treatment-of-unresectable-hepatocellular-carcinoma-hcc-100509300","NCT05911633","BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)","BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC): Prospective, Single Arm, Multi-center, Post-Market Clinical Follow-up (PMCF) Study","BIOPEARL-ONE","Inclusion Criteria:\n\n1. Subject is at least 18 years old\n2. Subject with HCC confirmed by histology or according to the latest applicable version of EASL (the European Association for the Study of the Liver) criteria\n3. Subject with tumor(s) \\\u003C 5 cm and within the up-to-7 criteria: the sum of the diameter of the largest tumor (in cm) and the number of tumors must be ≤ 7.0\n4. Subject with BCLC (Barcelona Clinic Liver Cancer) Stage A or B classification who is not a candidate for curative treatment at the time of study inclusion\n5. Subject with treatment failure\u002Frecurrence after a prior resection\u002Fablation is permitted, with the exception of recurrence in the segment of a prior thermal ablation\n6. WHO (World Health Organization) or ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1\n7. Subject deemed treatable in one session for initial treatment\n8. Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh Class A)\n9. Total bilirubin ≤ 2.0 mg\u002Fdl\n10. Adequate bone marrow function: Hemoglobin ≥ 9g\u002Fdl, absolute neutrophil count ≥ 1.0 x 109\u002FL, platelet count ≥ 75 x 109\u002FL\n11. Subject with no ascites or with minor ascites controlled by sodium dietary restrictions (subject receiving diuretic treatment or paracentesis is not eligible)\n12. Adequate renal function: serum creatinine \\\u003C 1.5 X ULN (Upper Limit of Normal)\n13. Subject has provided written informed consent\n14. Subjects of childbearing\u002Freproductive potential should use adequate birth control measures, during the study treatment period until survival follow-up\n\nExclusion Criteria:\n\n1. Subject previously treated with any systemic therapy for HCC\n2. Subject previously treated with intra-arterial loco-regional therapy for HCC\n3. Eligible for curative treatment at the time of study inclusion\n4. Recurrence in the segment of a prior thermal ablation\n5. Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding, encephalopathy\n6. Advanced tumoral disease: BCLC class C or D (vascular invasion - even segmental, extra-hepatic spread or cancer-related symptoms performance status \\>1)\n7. History of another primary tumor. Exceptions include:\n\n   A. Malignancy treated with curative intent ≥ 5 years before inclusion and with no known active disease\n\n   B. Malignancy which occurred \\\u003C 5 years before, not active and not expected to recur or be clinically relevant in the next 5 years\n8. Subject with history of biliary tree disease or biliary dilatation\n9. Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated\n10. Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media)\n11. Any other contraindication for embolization procedure or Doxorubicin treatment\n12. Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints\n\n    Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials\n13. In the Investigator's opinion subject has (a) co-morbid condition(s) that could limit the subject's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study\n14. Pregnant or breast-feeding woman",{"count":377,"type":21},50,[24],"The primary objective of the study is to confirm safety and technical success of BioPearl™ microspheres loaded with Doxorubicin in the treatment of unresectable hepatocellular carcinoma (HCC). The secondary objective of the study is to investigate the efficacy of BioPearl™ microspheres loaded with Doxorubicin in the treatment of subjects with unresectable HCC.",[30],[30,109,382,383],"TACE","Chemoembolization","2025-01-20",{"date":386,"type":35},"2025-01-22",{"date":388,"type":35},"2024-02-27",{"date":390,"type":21},"2027-12-30",{"name":392,"class":393},"Terumo Europe N.V.","INDUSTRY",10,{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":394},"100575990","phase-3-a-clinical-trial-assessing-the-safety-and-efficacy-of-biodegradable-magnesium-embolic-microspheres-for-primary-hepatocellular-carcinoma-100575990","NCT06779461","A Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma","A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Age range: 18 to 80 years inclusive, regardless of gender;\n2. Patients with primary hepatocellular carcinoma (HCC) at CNLC stage Ib to IIIa who require transarterial chemoembolization (TACE) treatment and are unsuitable for or refuse surgical resection, liver transplantation, and ablation therapy;\n3. ECOG score ≤ 2, and Child-Pugh classification of A or B;\n4. Presence of at least one untreated, measurable tumor lesion with a diameter ≥ 3.0 cm according to mRECIST criteria (the maximum diameter of the target lesion ≤ 10.0 cm);\n5. Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection who are willing to receive antiviral treatment throughout the study period;\n6. Voluntary participation in this clinical trial and signing of the informed consent form by the subject.\n\nExclusion Criteria:\n\n1. Patients with prior embolization or other local treatments within 28 days before enrollment, or needing combined local treatment with TACE;\n2. Received other antitumor systemic treatment within 28 days before enrollment;\n3. Unsuitable for TACE due to lesion characteristics or vascular issues;\n4. Vp3\u002FVp4 portal vein tumor thrombus;\n5. Tumor occupying ≥70% of liver volume;\n6. Decompensated cirrhosis or recent ascites drainage\u002FTIPS;\n7. Severe allergies to contrast agents or embolization materials;\n8. Received blood products or certain corrective treatments within 7 days before enrollment;\n9. Abnormal blood counts (WBC, platelets, neutrophils, hemoglobin);\n10. Abnormal liver function tests (bilirubin, enzymes, albumin);\n11. Renal impairment (creatinine, creatinine clearance);\n12. Prolonged PT;\n13. Unsuitable feeding artery for TACE or embolization risks;\n14. Expected survival \\\u003C6 months;\n15. Pregnant, lactating, or planning pregnancy;\n16. Factors affecting study results or necessitating study termination (alcoholism, drug abuse, severe diseases);\n17. Severe infections unsuitable for TACE;\n18. Participation in other clinical trials within 28 days before enrollment;\n19. Other reasons deemed unsuitable by the investigator.",{"count":403,"type":21},228,[357],"The goal of this clinical trial is to determine if the addition of biodegradable magnesium metal microspheres to traditional TACE (Transarterial Chemoembolization) is effective in treating hepatocellular carcinoma, and to assess the safety of these microspheres.\n\nThe main questions it aims to answer are:\n\n* Is the treatment more effective than traditional TACE alone?\n* What additional medical issues arise when using the microspheres?\n\nResearchers will compare TACE with magnesium microspheres to traditional TACE without microspheres to see if the addition of the microspheres improves treatment outcomes.\n\nParticipants will:\n\n* Receive up to 3 treatments of TACE with or without microspheres\n* Undergo checkups and tests every 30 days\n* Keep records of tumor size and other safety issues",[335],"2025-01-10",{"date":409,"type":35},"2025-01-16",{"date":411,"type":21},"2025-01",{"date":413,"type":21},"2027-12",{"name":415,"class":393},"InnoBM Pharmaceuticals Co., Ltd.",{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":176,"enrollmentInfo":423,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":425,"conditions":426,"keywords":427,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":4},"100565542","fecal-microbiota-transplantation-in-reversing-drug-resistance-in-unresectable-hcc-talenp004-100565542","NCT06643533","Fecal Microbiota Transplantation in Reversing Drug Resistance in Unresectable HCC (TALENP004)","Safety and Efficacy of Fecal Microbiota Transplantation in Reversing Drug Resistance in Patients With Intermediate-advanced Unresectable Hepatocellular Carcinoma Undergoing Transcatheter Arterial Chemoembolization Combined With Lenvatinib Plus Sintilimab.","Inclusion Criteria:\n\n1. Patients with intermediate to advanced Hepatocellular Carcinoma (HCC) who have experienced disease progression (PD) after treatment with the triple therapy of Transarterial Chemoembolization (TACE), lenvatinib, and sintilimab.\n2. Patients must have at least one measurable lesion according to the mRECIST 1.1 criteria (the longest diameter of measurable lesions on CT\u002FMRI scan ≥10mm).\n3. Expected survival time greater than 3 months.\n4. No prior treatment with Fecal Microbiota Transplantation (FMT).\n5. No history of taking probiotics after the diagnosis of HCC.\n6. Child-Pugh class A\u002FB.\n7. ECOG performance status: ≤1.\n8. Age between 18 and 75 years old.\n9. No other antitumor treatments except the triple therapy before enrollment.\n10. Key organ function indicators meet the following requirements:\n\n    Hematology: Absolute neutrophil count ≥1.5×10\\^9\u002FL, Hb ≥9.0g\u002FL, Platelets ≥75×10\\^9\u002FL Liver function: Total bilirubin ≤1.5 times the upper limit of normal (ULN) (≤2.5 times ULN after biliary drainage for obstructive jaundice); Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤5 times ULN, Albumin ≥30g\u002FL Renal function: Serum creatinine ≤1.5mg\u002FdL, Creatinine clearance rate ≥60ml\u002Fmin Coagulation function: International normalized ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤1.5 times ULN\n11. No history of severe arrhythmias, heart failure, severe ventilatory dysfunction, or severe pulmonary infections.\n12. Women of childbearing age must agree to use contraceptive measures during the treatment period and for 6 months after the end of treatment, with a negative serum or urine pregnancy test within 7 days before study enrollment, and must not be breastfeeding. Men must agree to use contraceptive measures during the study period and for 6 months after the end of the study.\n\nExclusion Criteria:\n\n1. Mixed hepatocellular-cholangiocarcinoma.\n2. Severe tumor progression (tumor volume occupies two-thirds or more of the liver volume or diffuse intrahepatic lesions).\n3. History of allergy to PD-1, lenvatinib, or their components.\n4. History of other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid cancer.\n5. Patients who have undergone organ transplantation or are planning to undergo organ transplantation.\n6. Any active autoimmune disease or autoimmune disease with expected recurrence (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes).\n7. History of immunodeficiency; patients who are using immunosuppressants or systemic corticosteroid therapy for immunosuppression and have continued use within 2 weeks before signing the informed consent.\n8. Known hereditary or acquired bleeding (such as coagulation disorders) or thrombotic tendencies, such as hemophilia patients; currently using or have recently (within 10 days before the start of the study treatment) used full-dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes (preventive use of low-dose aspirin, low molecular weight heparin is allowed).\n9. Serious infections within 4 weeks before enrollment, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging indicates active pulmonary inflammation, presence of infection symptoms and signs or need for oral or intravenous antibiotic treatment within 2 weeks before the first use of the study drug (excluding the use of antibiotics for prevention).\n10. Patients with mental illness; history of abuse of psychotropic drugs, alcoholism, and drug addiction.\n11. Chronic intestinal diseases (such as celiac disease, malabsorption, etc.).\n12. Pregnant or breastfeeding women.\n13. Deemed by the investigator to be unsuitable for participation in this trial for other reasons.",{"count":424,"type":21},15,"This study aims to evaluate the safety and efficacy of fecal microbiota transplantation (FMT) in reversing drug resistance to the triple therapy regimen in patients with unresectable hepatocellular carcinoma (HCC). The triple therapy consists of transarterial chemoembolization (TACE), lenvatinib, and Sintilimab. The study is a prospective, single-arm, multicenter clinical trial involving 15 participants with mid-to-late stage HCC that has progressed despite the triple therapy. FMT capsules will be prepared by matching the gut microbiome profiles of healthy donors to those of patients who achieved complete response (CR) with the triple therapy. The primary endpoints include objective response rate (ORR), treatment-related adverse events (AEs). Secondary endpoints will assess overall survival (OS), progression-free survival (PFS), and disease control rate (DCR), changes in gut microbiome, metabolomics, and immune subsets before and after FMT.",[30],[428,27,382,212,429],"Fecal Microbiota Transplantation","PD-1 inhibitor","2024-10-13",{"date":432,"type":35},"2024-10-16",{"date":434,"type":21},"2025-01-01",{"date":436,"type":21},"2027-12-31",{"name":438,"class":42},"Fujian Provincial Hospital",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":176,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":43},"100562741","phase-2-mfolfox7-plus-camrelizumab-and-apatinib-in-bclc-stage-ab-hepatocellular-carcinoma-patients-beyond-milan-criteria-100562741","NCT06607107","mFOLFOX7 Plus Camrelizumab and Apatinib in BCLC Stage A\u002FB Hepatocellular Carcinoma Patients Beyond Milan Criteria","A Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Systemic Chemotherapy(mFOLFOX7) Combined With Camrelizumab and Apatinib in BCLC Stage A\u002FB Hepatocellular Carcinoma Patients Beyond Milan Criteria","Inclusion Criteria:\n\n1. Before treatment, histologically or cytologically or clinically diagnosed as hepatocellular carcinoma (HCC) and the clinical stage belongs to BCLC stage A\u002FB HCC that exceeds the Milan criteria.\n2. Child-pugh liver function grading: Grade A or B\n3. Did not received any type of other first-line drugs such as Sorafenib or Lenvatinib.\n4. According to RECIST 1.1 standard and mRECIST standard, patients have at least one measurable lesion (CT scan long diameter ≥10mm and the lesion has not received radiotherapy, freezing or other local treatments)；\n5. ECOG PS score 0-2;\n6. Expected survival ≥ 12 weeks;\n7. Blood routine:White blood cells count ≥3.0×10\\^9\u002FL Platelet count ≥70×10\\^9\u002FL Hemoglobin ≥80g\u002FL(without blood transfusion within 14 days); kidney function: Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN); Liver function:Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); AST or ALT levels ≤ 3 times the upper limit of normal value (ULN)\n8. Patients with hepatitis B or C coinfection need to use antiviral drugs and have not used interferon.\n9. Women of childbearing age should have a negative serum or urine pregnancy test within 7 days before enrollment and they must be non-lactating patients and agree to use contraceptive measures during the study period and within 6 months after the end of the study. Men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period.\n10. Patients volunteered to participate in this study and signed informed consent;\n\nExclusion Criteria:\n\n1. Have received immunotherapeutic drugs or interferon in the past.\n2. Allergic to the drugs in the treatment ;\n3. Female subjects with pregnancy or on feeding.\n4. Have received other immunotherapy drugs (targeting PD1\u002FPDL1).\n5. Patients with combined uncontrolled cardiac clinical symptoms or diseases, such as: (1) heart failure above NYHA class II; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; (5) those with poorly controlled hypertension by drugs and assessed by doctors as having a high risk of using apatinib.\n6. Past medical history includes other tumors or a second tumor, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ and papillary thyroid cancer.\n7. Combined with severe infection (CTCAE greater than grade 2) before the start of treatment, such as severe pneumonia requiring hospitalization, active tuberculosis, bacteremia, infectious complications, etc.; baseline chest imaging examination indicates active pulmonary inflammation. There are symptoms and signs of infection within 2 weeks before the first use of the study drug or oral or intravenous antibiotic treatment is required (excluding prophylactic use of antibiotics).\n8. Have a history of immunodeficiency, such as positive HIV monitoring, have other acquired or congenital immunodeficiency diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes), or have a history of organ transplantation or bone marrow transplantation; or are taking hormones or other immunosuppressive drugs orally or intravenously; but excluding vitiligo or cured childhood asthma\u002Fallergies, and patients who do not require any intervention as adults.\n9. Severe coagulation disorders (INR\\>2.0, PT\\>16s), those with obvious bleeding tendencies (including but not limited to vomiting blood and having bloody stools every day in the past 3 months).\n10. Have the history of abusing psychotropic drugs and unable to quit ,or with mental disorders; with brain metastases or hepatic encephalopathy.\n11. As judged by the investigator, the patient may have other factors that may cause the study to be terminated prematurely, such as other serious diseases or serious abnormal laboratory tests or accompanied by other family or social factors that will affect the safety of the subject or the collection of trial data and samples.",{"count":447,"type":21},29,[78],"This study was designed to evaluate the effectiveness and safety of mFOLFOX7（Oxaliplatin,Calcium Levofolinate,Fluorouracil） combined with Apatinib and Camrelizumab for Hepatocellular Carcinoma.\n\nThe primary outcome measure is to evaluate the primary pathological response (MPR) rate of the therapy for Hepatocellular Carcinoma.\n\nThe secondary Outcome measures include the objective response rate (ORR), the duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) \\[ Time Frame: 6- and 12-month\\], overall survival rate (OSR) \\[ Time Frame: 6- and 12-month\\], the median progression-free survival time (mPFS) and median overall survival time (mOS) of the therapy for Hepatocellular Carcinoma.\n\nMoreover, this study aims to assess the safety and tolerability of the Therapy for Hepatocellular Carcinoma.",[30],"2024-09-20",{"date":453,"type":35},"2024-09-23",{"date":455,"type":35},"2024-02-17",{"date":457,"type":21},"2028-01-11",{"name":459,"class":42},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":176,"enrollmentInfo":467,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":468,"conditions":469,"keywords":470,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":481},"100559228","triple-therapy-sequential-radiotherapy-in-unresectable-hcc-talenp003-100559228","NCT06561399","Triple Therapy Sequential Radiotherapy in Unresectable HCC (TALENP003)","A Single-arm, Phase II, Prospective Study of Transcatheter Arterial Chemoembolization, Lenvatinib Combination With Sintilimab Sequential Radiotherapy in Patients With Initial Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Be willing and able to enrollment in this study, signing the informed consent form;\n2. Age between 18 and 75 years old, male or female patients;\n3. Child-Pugh class A;\n4. Indocyanine green 15 min retention rate (ICGR-15) \\\u003C15%;\n5. ECOG score 0-1;\n6. Diagnosis of hepatocellular carcinoma according to the Chinese HCC Diagnosis and Treatment Guidelines 2022 Edition and expected survival time greater than 4 months.\n7. Patients with a diagnosis of initial unresectable HCC (BCLC stage B or C), evaluated as partial response (PR) or stable disease (SD) by RECIST 1.1 after 2 months of treatment with TACE, Lenvatinib combination with Sintilimab. The number of residual active lesions in the liver was 1 to 3 and suitable for radiation therapy. Fusion lesions in the liver were considered as 1 lesion, and portal vein cancer thrombus was considered as 1 lesion for treatment.\n8. Normal tissue limits were performed according to the UK Consensus on Normal Tissue Dose Constraints for Stereotactic Radiotherapy.\n9. Patients who have not received any tumor-related targeted, immunotherapy, radiotherapy and chemotherapy before enrollment;\n10. Patients with at least one measurable lesion according to RECIST 1.1 criteria (measurable lesion CT\u002FMRI scan length diameter ≥10mm, and measurable lesion has not received localized treatments such as radiotherapy, cryotherapy, etc.);\n11. Blood routine: absolute neutrophil count ≥1.5×10\\^9\u002FL, Hb ≥8.5g\u002FL, PLT ≥75×10\\^9\u002FL;\n12. No history of severe cardiac arrhythmia or heart failure; no history of severe ventilatory dysfunction or severe pulmonary infection; no acute or chronic renal failure with creatinine clearance \\>40 mL\u002Fmin;\n13. Women of childbearing age should agree that they must use contraception during and for 6 months after the end of the dosing period; patients who have had a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating, and men should agree that they must use contraception during and for 6 months after the end of the study period.\n\nExclusion Criteria:\n\n1. Patients with a diagnosis of initial unresectable HCC, assessed as complete response (CR) or Progressive disease (PD) by RECIST 1.1 after 2 months of treatment with TACE, Lenvatinib combined with Sintilimab;\n2. Tumor combined with cancerous thrombus in the inferior vena cava and the tumor has developed extrahepatic metastasis;\n3. Treatment with other antitumor therapy such as targeted drugs, PD-1\u002FPD-L1 inhibitors, surgery, TACE, radiotherapy, FOLFOX systemic chemotherapy, and locus coeruleus granule drugs prior to study entry;\n4. History of allergy to Lenvatinib, Sintilimab and their components;\n5. Tumor volume accounting for two-thirds or more of the liver volume or diffuse distribution of intrahepatic lesions;\n6. Presence of any active autoimmune disease or patients with autoimmune disease with expected relapse (e.g., interstitial pneumonitis, colitis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including, but not limited to, these disorders and syndromes); hypothyroidism treated with stabilized doses of thyroid-replacing hormone; 1-year old diabetes mellitus using stabilized doses of insulin; or Type 1 diabetes mellitus; but not vitiligo or resolved childhood asthma\u002Fallergies that do not require any intervention in adulthood;\n7. Patients have history of immunodeficiency; patients who are on immunosuppressive or systemic hormone therapy for immunosuppression and have continued to do so within 2 weeks prior to signing the informed consent form\n8. Have known hereditary or acquired bleeding (e.g., coagulation disorders) or thrombotic tendencies, such as in patients with hemophilia; current or recent (within 10 days prior to initiation of study treatment) use of full-dose oral or injectable anticoagulant or thrombolytic medications for therapeutic purposes (prophylactic use of low-dose aspirin, low-molecular heparin is permitted)\n9. Severe infections (CTCAE \\> Grade 2) such as severe pneumonia requiring hospitalization, bacteremia, or infectious co-morbidities within 4 weeks prior to the first dose of study drug; baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection within 2 weeks prior to the first dose of study drug, or requiring treatment with oral or intravenous antibiotics (excluding prophylactic antibiotics). (excluding prophylactic use of antibiotics);\n10. Patients with proteinuria with routine urinalysis suggestive of ≥ 1 + will undergo a 24-hour urine protein test for 24-hour urine protein ≥ 1g;\n11. Have history of other malignant tumors within the previous 5 years or concurrently, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix and papillary thyroid carcinoma;\n12. Patients with co-morbid mental diseases; history of psychotropic substance abuse, alcoholism and drug addiction;\n13. Women who are pregnant or breastfeeding\n14. Patients with obvious contraindications to surgery, such as renal and cardiopulmonary insufficiency, as judged by the investigator, and those who, in the opinion of the investigator, should not participate in this trial for other reasons.",{"count":5,"type":21},"This is an Open-label, Multicenter, Phase II clinical trial to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combination with Sintilimab (Triple Therapy) sequential radiotherapy in patients with Unresectable Hepatocellular Carcinoma (uHCC).",[30],[82,382,212,471,472],"Sintilimab","radiotherapy","2024-08-18",{"date":475,"type":35},"2024-08-20",{"date":477,"type":21},"2024-08-15",{"date":479,"type":21},"2028-07-01",{"name":438,"class":42},4,{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":22,"phases":491,"briefSummary":492,"conditions":493,"keywords":494,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":4},"100557255","phase-2-a-phase-2-single-arm-study-of-cabozantinib-in-patients-with-hepatocellular-carcinoma-who-have-received-prior-atezolizumab-and-bevacizumab-100557255","NCT06535737","A Phase 2, Single Arm Study of Cabozantinib in Patients With Hepatocellular Carcinoma Who Have Received Prior Atezolizumab and Bevacizumab","CPAB","Inclusion Criteria:\n\n* Radiological, histological or cytological diagnosis of HCC\n* The subject has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, radiofrequency ablation)\n* Received prior atezolizumab and bevacizumab\n* Progression following atezolizumab and bevacizumab treatment for advanced HCC\n* Recovery to ≤ Grade 1 from toxicities related to any prior treatments, unless the adverse events are clinically nonsignificant and\u002For stable on supportive therapy\n* Age ≥ 18 years old on the day of consent\n* ECOG performance status of 0 or 1\n* Adequate hematologic function, based upon meeting the following laboratory criteria within 7 days before enrollment:\n\n  * absolute neutrophil count (ANC) ≥ 1200\u002Fmm3 (≥ 1.2 x 109\u002FL)\n  * platelets ≥ 60,000\u002Fmm3 (≥ 60 x 109\u002FL)\n  * hemoglobin ≥ 8 g\u002FdL (≥ 80 g\u002FL)\n* Adequate renal function, based upon meeting the following laboratory criteria within 7 days before enrollment:\n\n  * serum creatinine ≤ 1.5 × upper limit of normal or calculated creatinine clearance ≥ 40 mL\u002Fmin (using the Cockroft-Gault equation: (140 - age) x weight (kg)\u002F(serum creatinine × 72 \\[mg\u002FdL\\]) for males. (For females multiply by 0.85.) AND\n  * urine protein\u002Fcreatinine ratio (UPCR) ≤ 1 mg\u002Fmg (≤ 113.1 mg\u002Fmmol) or 24-hour urine protein \\\u003C 1g\n* Child-Pugh Score of A or B7\n* Total bilirubin ≤ 2 mg\u002FdL (≤ 34.2 μmol\u002FL) within 7 days before enrollment\n* Serum albumin ≥ 2 g\u002FdL (≥ 20 g\u002FL) within 7 days before enrollment\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 5.0 upper limit of normal (ULN) within 7 days before enrollment\n* Hemoglobin A1c (HbA1c) ≤ 8% within 7 days before enrollment\n* Antiviral therapy per local standard of care if active hepatitis B (HBV) infection\n* Capable of understanding and complying with the protocol requirements and signed informed consent\n* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment\n* Female subjects of childbearing potential must not be pregnant at screening. Females of childbearing potential are defined as premenopausal females capable of becoming pregnant (ie, females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression, low body weight, or other reasons.\n\nExclusion Criteria:\n\n* • Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma\n* Receipt of more than one prior systemic therapy for advanced HCC. Additional prior systemic therapies used as adjuvant or local therapy are allowed.\n* Any type of anticancer agent (including investigational) within 2 weeks before enrollment\n* Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment (eg, I-131 or Y-90) within 6 weeks of enrollment. Subject is excluded if there are any clinically relevant ongoing complications from prior radiation therapy.\n* Prior cabozantinib treatment\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 3 months before enrollment. Eligible subjects must be without corticosteroid treatment at the time of enrollment.\n* Concomitant anticoagulation, at therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, low molecular weight heparin (LMWH), thrombin or coagulation factor X (FXa) inhibitors, or antiplatelet agents (eg, clopidogrel). Low-dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (≤ 1 mg\u002Fday), and low-dose LMWH are permitted.\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders including\n  * Symptomatic congestive heart failure, unstable angina pectoris, or serious cardiac arrhythmias\n* Uncontrolled hypertension defined as sustained BP \\> 150 mm Hg systolic, or \\> 100 mm Hg diastolic despite optimal antihypertensive treatment\n* Stroke (including TIA), myocardial infarction, or other ischemic event within 6 months before enrollment\n* Thromboembolic event within 3 months before enrollment. Subjects with thromboses of portal\u002Fhepatic vasculature attributed to underlying liver disease and\u002For liver tumor are eligible\n\n  o Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n* Tumors invading the GI tract, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction\n* Abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess within 6 months before enrollment, Note: Complete healing of an intra-abdominal abscess must be confirmed prior to enrollment\n\n  * Major surgery within 2 months before enrollment. Complete healing from major surgery must have occurred 1 month before enrollment. Complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before enrollment. Subjects with clinically relevant complications from prior surgery are not eligible\n  * Cavitating pulmonary lesion(s) or endobronchial disease\n  * Lesion invading a major blood vessel (eg, pulmonary artery or aorta)\n  * Clinically significant bleeding risk including the following within 3 months of enrollment: hematuria, hematemesis, hemoptysis of \\>0.5 teaspoon (\\>2.5 mL) of red blood, or other signs indicative of pulmonary hemorrhage, or history of other significant bleeding if not due to reversible external factors\n  * Other clinically significant disorders such as:\n* Active infection requiring systemic treatment, known infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)-related illness\n* Serious non-healing wound\u002Fulcer\u002Fbone fracture\n* Malabsorption syndrome\n* Uncompensated\u002Fsymptomatic hypothyroidism\n* Requirement for hemodialysis or peritoneal dialysis\n* History of solid organ transplantation\n* 9\\. Subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding are excluded with the following clarification: subjects with history of prior variceal bleeding must have been treated with adequate endoscopic therapy without any evidence of recurrent bleeding for at least 6 months prior to study entry and must be stable on optimal medical management (e.g. non-selective beta blocker, proton pump inhibitor) at study entry.\n* Moderate or severe ascites\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms within 7 days before enrollment\n* Note: If the QTcF is \\> 500 ms in first ECG, a total of 3 ECGs should be performed. If the average of these 3 consecutive results for QTcF is ≤ 500 ms, the subject meets eligibility in this regard.\n* Inability to swallow tablets\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations\n* Pregnant or lactating females\n* Diagnosis of another malignancy within 2 years before enrollment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy",{"count":490,"type":21},40,[78],"Hepatocellular carcinoma (HCC) is the most common liver cancer and a leading cancer death worldwide. Currently, atezolizumab and bevacizumab combination is the standard of care for patients with advanced HCC. There have not been proven therapy for patients with advanced HCC previously treated with atezolizumab and bevacizumab. Cabozantinib is a proven therapy for patients with advanced HCC previously treated with sorafenib. The study aims to demonstrate the efficacy and safety of cabozantinib in patients with advanced previously treated with atezolziumab and bevacizumab. It is a multi-center single-arm study which all participants will receive cabozantinib. Participants will continue cabozantinib until. disease progression or unacceptable toxicities.",[30],[82,495],"Cabozantinib","2024-07-31",{"date":498,"type":35},"2024-08-02",{"date":500,"type":21},"2024-08",{"date":502,"type":21},"2026-12",{"name":504,"class":42},"Chulalongkorn University",{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":176,"enrollmentInfo":513,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":520,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":43},"100553559","tace-combined-with-immune-checkpoint-inhibitors-for-liver-malignant-tumors-100553559","NCT06487663","TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors","Transcatheter Hepatic Artery Chemoembolization Combined With Immune Checkpoint Inhibitors for Liver Tumors","TIKET","Inclusion Criteria:\n\n* Confirmed diagnosis of HCC by histology\u002F cytology or clinical criteria\n* Sign informed consent\n* When screening for age, the age should be ≥ 18 years old\n* Eligible for TACE treatment\n* ECOG physical condition score is 0 or 1\n* No prior systemic therapy for HCC, especially immunotherapy\n* According to the following mRECIST criteria, at least one measurable intrahepatic lesion is suitable for repeated evaluation\n\nExclusion Criteria:\n\n* Have any history of kidney disease or nephrotic syndrome\n* Evidence of extrahepatic spread (EHS)\n* Cardiovascular diseases with clinical significance (such as activity), including unstable angina, ≥ grade 2 congestive heart failure, and arrhythmia with poor drug treatment control\n* Any condition representing a contraindication to TACE as determined by the investigators\n* Known genetic factors for bleeding or thrombosis; Any previous or current evidence indicating a tendency for bleeding\n* Individuals who have received immunotherapy (anti PD-1, anti PD-L1, or anti CTLA-4 treatment)\n* Previously received HAIC (hepatic artery infusion chemotherapy), TACE (hepatic artery chemoembolization), TAE (hepatic artery embolization), or TARE (hepatic artery radiation embolization)\n* Previously received systemic anti-cancer treatment for HCC ,ICC or liver metastasis.",{"count":490,"type":21},[24],"This study will evaluate the efficacy and safety of TACE combined with immune checkpoint inhibitors to treat unresectable hepatocellular carcinoma.",[30,517,518,519],"Cholangiocarcinoma Non-resectable","Liver Metastases","Liver Malignant Tumors",[27,521,518,519],"Cholangiocarcinoma","2024-06-27",{"date":524,"type":35},"2024-07-05",{"date":526,"type":35},"2020-10-27",{"date":528,"type":21},"2026-10-27",{"name":530,"class":42},"Tianjin Medical University Cancer Institute and Hospital",{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":537,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":540,"conditions":541,"keywords":542,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":481},"100494404","combined-tace-tkianti-vegf-and-icis-as-conversion-therapy-for-advanced-hepatocellular-carcinoma-100494404","NCT05717738","Combined TACE, TKI\u002FAnti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma","Combined Transarterial Chemoembolization, Tyrosine Kinase Inhibitor\u002F Anti-VEGF Antibody, and Anti-PD-1\u002F PD-L1 Antibody as Conversion Therapy for Advanced Hepatocellular Carcinoma: a Multicenters, Real-world, Ambispective Cohort Study","CCGLC-008","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Diagnosis of HCC is according to the American Association for the Study of Liver Diseases or European Association for the Study of the Liver guidelines of HCC management;\n3. at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or mRESIST criteria.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n5. Hepatocellular carcinoma (HCC) was assessed as not suitable for radical resection, liver transplant, or ablation treatment after the assessment of a multidisciplinary team because either: (1) R0 resection was not feasible; (2) remnant liver volume was less than 30% in patients who did not have cirrhosis or 40% in patients with cirrhosis, or the results of an indocyanine green test were higher than 15%; (3) patients had Barcelona Clinic Liver Cancer (BCLC) stage B or BCLC stage C.\n6. portal vein involvement (Chen's groups A, or Cheng's type I-II) is allowed: Chen's group A1 or Cheng's type I, tumor thrombus is involved in segmental or sectoral branches of the portal vein or above; Chen's group A2 or Cheng's type II, involvement of the first branch of portal vein.\n7. hepatic vein invasion (VV1 to VV2) were allowed.\n8. Patients with extrahepatic oligometastasis is allowed: extrahepatic oligometastasis was defined as up to three metastatic lesions in up to two organs with the largest diameter of 3 cm\n9. Child-Pugh liver function class A-B7\n10. No prior transplantation, TACE, or radioembolization to the liver was allowed. Prior locoregional therapies, such as surgical resection, radiotherapy, radiofrequency ablation, percutaneous ethanol injection or cryoablation, are allowed if the disease have progressed since prior treatment. Local therapy must have been completed at least 4 weeks prior to the baseline scan.\n11. Adequate organ and marrow function, as defined below:\n\n(1) Hemoglobin ≥80 g\u002FL (2) Absolute neutrophil count ≥1.5 ×109\u002FL (3) Platelet count ≥50 ×109\u002FL (4) Total bilirubin \\\u003C 51 μmol\u002FL (5) Alanine transaminase (ALT) and aminotransferase (AST)≤5×ULN (6) Albumin ≥28 g\u002FL (7) INR ≤1.6 (8) Serum creatinine \\\u003C 110 μmol\u002FL 12. Time interval between TACE and systemic therapy within 7 days.\n\nExclusion Criteria:\n\n1\\. Prior invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, lobular or ductal carcinoma in situ of the breast that has been surgically cured 2. Severe, active and uncontrolled co-morbidity including but not limited to:\n\n1. Persistent or activity (except the HBV and HCV) infection;\n2. symptoms of congestive heart failure and uncontrolled diabetes;\n3. uncontrolled hypertension, systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg despite anti-hypertension medications ≤ 28 days before randomization or first dose of drug.\n4. unstable angina,\n5. uncontrolled arrhythmias,\n6. active ILD,\n7. severe chronic GI disease accompanied by diarrhea,\n8. compliance with requirements may limit the research, resulted in significant increase risk of AE or influence Subjects provided psychiatric\u002Fsocial problem status on their ability to provide written informed consent.\n9. A history of active primary immunodeficiency or human immunodeficiency virus; (10) Active or previous records of autoimmune disease or inflammatory diseases, including inflammatory bowel disease (e.g., colitis or Crohn's disease\\], diverticulitis, except \\[diverticulosis\\], systemic lupus erythematosus (SLE), sarcoidosis syndrome or Wegener syndrome (e.g., granulomatous vasculitis, gray's disease, rheumatoid arthritis, the pituitary gland inflammation and uveitis\\]).\n\n(11) A history of hepatic decompensation, including refractory ascites, gastrointestinal bleeding, or hepatic encephalopathy; 3. Known to produce allergic or hypersensitive reactions to any study drug or any excipient thereof; 4. Significant clinical gastrointestinal bleeding or a potential risk of bleeding was identified by the investigator during the 30 days prior to study entry.\n\n5\\. Tumors of the central nervous system, including metastatic brain tumors; 6. Pregnant women or breast-feeding patients; 7. Has received anti-tumor system therapy for HCC. Non-anti-tumor purpose combined hormone therapy (e.g., hormone replacement therapy) is excluded.\n\n8\\. Is currently using, or has used an immunosuppressive drug within 14 days prior to the first dose of the investigational drug. This standard has the following exceptions: (1) intranasal, inhaled, topical or topical steroids. (e.g., intraarticular) (2) Systemic corticosteroid therapy not exceeding 10 mg\u002F day of prednisone; (3) prophylactic use of steroids for hypersensitivity. (e.g., CT scan pretherapy medication) 9. A live attenuated vaccine was administered within 30 days prior to the first administration of the study drug. Note: If enrolled, patients shall not receive live attenuated vaccine within 30 days of receiving study drug therapy and after the last administration of study drug.\n\n10\\. Extrahepatic vascular involvement or thrombosis: main trunk of portal vein and superior mesenteric vein (Cheng's type III and IV) or inferior vena cava (IVC) (VV3).",{"count":131,"type":21},"The aim of this study is to the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of transarterial chemoembolization (TACE), Anti-VEGF antibodies or pan-target anti-angiogenic drugs, and anti-PD-1\u002F PD-L1 antibody for advanced hepatocellular carcinoma which initially unsuitable for the radical therapy, including resection, transplantation, or ablation.",[30],[27,543],"Downstaging conversion therapy","2024-06-12",{"date":546,"type":35},"2024-06-13",{"date":548,"type":35},"2022-01-20",{"date":550,"type":21},"2024-12-31",{"name":552,"class":42},"Tongji Hospital",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":22,"phases":563,"briefSummary":564,"conditions":565,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":574},"100379750","phase-2-atezolizumabbevacizumab-followed-by-on-demand-tace-or-initial-synchronous-treatment-with-tace-and-atezolizumabbevacizumab-100379750","NCT04224636","Atezolizumab\u002FBevacizumab Followed by On-demand TACE or Initial Synchronous Treatment With TACE and Atezolizumab\u002FBevacizumab","A Randomized, 2-arm Non-comparative Phase II Study on the Efficacy of Atezolizumab and Roche Bevacizumab (Atezo\u002FBev) Followed by On-demand Selective TACE (sdTACE) Upon Detection of Disease Progression or of Initial Synchronous Treatment With TACE and Atezo\u002FBev on 24-months Survival Rate in the Treatment of Unresectable Hepatocellular Carcinoma Patients","DEMAND","Key Inclusion Criteria\n\n1. Patient's signed informed consent\n2. Age ≥18 years at time of signing Informed Consent Form\n3. Ability to comply with the study protocol, according to investigator's judgement\n4. Life expectancy of at least 12 weeks\n5. HCC with histologically confirmed diagnosis\n6. Disease that is not amenable to curative surgical and\u002For local ablation but eligible for TACE\n7. ECOG Performance Status of 0 or 1\n8. Child-Pugh class A or B7\n9. Adequate hematologic and end-organ function\n10. Negative HIV test at screening\n\nKey Exclusion Criteria\n\n1. Diffuse HCC or presence of vascular invasion or extrahepatic spread or more than 7 lesions or at least one lesion \\>= 7 cm\n2. Clinically relevant ascites\n3. Uncontrolled pleural effusion or pericardial effusion\n4. History or presence of hepatic encephalopathy\n5. Co-infection of HBV and HCV\n6. Patients on a liver transplantation list.\n7. Prior systemic therapy for HCC\n8. Prior treatment with TACE or selective internal radiation treatment (SIRT)\n9. Any condition representing a contraindication to TACE\n10. Major gastrointestinal bleeding within 4 weeks prior to randomization, untreated or incompletely treated varices with bleeding or high-risk for bleeding.\n11. Active or history of autoimmune disease or immune deficiency\n12. Prior allogeneic stem cell or solid organ transplantation\n13. 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\n14. Active tuberculosis\n15. Severe infection requiring antibiotics within 4 weeks prior to randomization\n16. Significant cardiovascular disease\n17. History of congenital long QT syndrome or corrected QT interval \\>500 ms at screening ECG\n18. Inadequately controlled arterial hypertension or prior history of hypertensive crisis or hypertensive encephalopathy\n19. Significant vascular disease including aortic aneurysm requiring surgical repair or peripheral arterial thrombosis with 6 months prior to randomization\n20. History of abdominal or tracheoesophageal fistula or gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization.\n21. History or clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding. Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure\n22. History of intra-abdominal inflammatory process within 6 months prior to randomization, including but not limited to peptic ulcer disease, diverticulitis, or colitis\n23. Evidence of bleeding diathesis or significant coagulopathy\n24. 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.\n25. Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at enrollment.\n26. Severe, non healing or dehisced wound, active ulcer, or untreated bone fracture\n27. History of malignancy other than HCC, with the exception of patients who have been disease-free for at least five years before enrollment or patients with adequately treated and completely resected basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer, stage I uterine cancer\n28. Current or recent (within 10 days of randomization) use of acetylsalicyclic acid or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol\n29. Current or recent (within 10 days prior to randomization) use of full dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purpose.\n30. Chronic daily treatment with a nonsteroidal anti-inflammatory drug (NSAID). Occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or fever is allowed.\n31. Treatment with a live, attenuated vaccine within 4 weeks prior to randomization, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the last dose of atezolizumab\n32. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and antiPD-L1 therapeutic antibodies\n33. Hypersensitivity to atezolizumab or bevacizumab or any of the excipients, known hypersensitivity to Chinese hamster ovary cell products, known hypersensitivity to human or humanized antibodies\n34. 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 randomization\n35. Treatment with systemic immunosuppressive medication within 2 weeks prior to randomization, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n    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.\n\n    Inhaled corticosteroids for chronic obstructive pulmonary disease or bronchial asthma, supplemental mineralocorticosteroids or low-dose corticosteroids for adrenalcortical insufficiency are allowed.\n36. Major surgical procedure other than for diagnosis, open biopsy, or significant traumatic injury within 28 days prior to randomization, or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to randomization or anticipation of need for major surgical procedure during the course of the study or non-recovery from side effects of any such procedure\n37. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 3 days prior to the first dose of bevacizumab\n38. Pregnant or breastfeeding females\n39. Participation in a clinical trial or experimental drug treatment within 28 days prior to inclusion in the clinical trial or within a period of 5 half-lives of the substances administered in a clinical trial or during an experimental drug treatment prior to inclusion in the clinical trial, depending on which period is longest, or simultaneous participation in another clinical trial while taking part in this clinical trial.\n40. Patient committed to an institution by virtue of an order issued either by the judicial or the administrative authorities\n41. Patient possibly dependent from the investigator including the spouse, children and close relatives of any investigator",{"count":562,"type":21},106,[78],"Aim of the study is to evaluate the efficacy of up-front atezolizumab\u002F bevacizumab (Atezo\u002FBev) followed by on-demand selective transarterial chemoembolization (sdTACE) and of initial synchronous treatment with TACE and Atezo\u002FBev in the treatment of unresectable HCC patients.",[30],{"date":567,"type":35},"2024-06-14",{"date":569,"type":35},"2020-06-10",{"date":571,"type":21},"2025-03-01",{"name":573,"class":42},"Ludwig-Maximilians - University of Munich",7,{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":176,"enrollmentInfo":582,"targetDuration":4,"studyType":22,"phases":584,"briefSummary":585,"conditions":586,"keywords":587,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":592,"leadSponsor":594,"locationsCount":43},"100546613","phase-2-sintilimab-plus-bevacizumab-and-sirt-for-intermediate-advanced-hcc-100546613","NCT06397222","Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC","Sintilimab, Bevacizumab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial","Inclusion Criteria:\n\n* Unresectable HCC (BCLC stage B\u002FC or CNLC II\u002FIII) with diagnosis confirmed by histology\u002Fcytology or clinically\n* At least one measurable untreated lesion\n* Intrahepatic tumors can be treated with 1-2 sessions of SIRT\n* Child-Pugh score 5-7\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1\n* Life expectancy of at least 3 months\n* Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\\\u003C10\\^3 IU\u002FmL\n* Patients with hepatitis C need to finish the anti-HCV treatment\n\nExclusion Criteria:\n\n* tumor extent ≥70% liver occupation\n* Tumor thrombus involving main portal vein or both the first left and right branches of portal vein\n* Vena cava invasion\n* Central nervous system metastasis\n* Metastatic disease that involves major airways or blood vessels\n* Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy for HCC\n* History of organ and cell transplantation\n* Prior esophageal and\u002For gastric varices bleeding\n* Hepatic dysfunction, such as ascites, esophagogastric varices, hepatic encephalopathy\n* Evidence of portal hypertension with high risk of bleeding\n* Use of immunosuppressive medications within 4 weeks prior to the first dose of study treatment\n* Major surgical procedure or unhealed wound, ulcer, or fracture within 4 weeks prior to the first dose of study treatment\n* Any life-threatening bleeding event within the previous 3 months, including the need for blood transfusion, surgical or localized treatment, or ongoing drug therapy\n* Peripheral blood white blood cell count \\\u003C3×10\\^9\u002FL and platelet count \\\u003C50×10\\^9\u002FL\n* Prolonged prothrombin time \\>4 seconds\n* Severe organ (heart, lung, kidney) dysfunction\n* History of other malignancies\n* Co-infection with hepatitis B and C viruses\n* Human immunodeficiency virus infection\n* Pregnant or lactating patients",{"count":583,"type":21},23,[78],"This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).",[30],[27,471,113,213],"2024-05-05",{"date":590,"type":35},"2024-05-07",{"date":319,"type":35},{"date":593,"type":21},"2027-04-30",{"name":198,"class":42},{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":176,"enrollmentInfo":602,"targetDuration":4,"studyType":22,"phases":603,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":43},"100544945","phase-2-ivonescimab-combined-with-haic-for-the-treatment-of-unresectable-hepatocellular-carcinomauhcc-100544945","NCT06375486","Ivonescimab Combined With HAIC for the Treatment of Unresectable Hepatocellular Carcinoma（uHCC）.","A Single-arm, Single-center, Phase II Clinical Study of AK112 (a Dual-specific Antibody Against PD-1\u002FVEGF) Combined With Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma.","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form.\n2. Age at enrollment is ≥ 18 years and ≤ 75 years, both males and females are eligible.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n4. Expected survival ≥ 3 months.\n5. Confirmed histologically\u002Fcytologically or cirrhotic patients meeting the Barcelona Clinic Liver Cancer (BCLC) stage B or C criteria for hepatocellular carcinoma (HCC) according to the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria.\n6. Not suitable for curative treatment (surgery or ablation) and have not previously received systemic anti-tumor therapy for unresectable HCC.\n7. Liver function classified as Child-Pugh class A.\n8. Sufficient organ function.\n\nExclusion Criteria:\n\n1. Components including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc., confirmed histologically\u002Fcytologically.\n2. Apart from HCC, subjects have had other malignant tumors within 5 years prior to enrollment. Subjects who have been cured of other malignant tumors through local treatment, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, cervical or breast carcinoma in situ, are not excluded. If diagnosed with liver cancer or other malignant tumors more than 5 years before dosing, pathological histology or cytology diagnosis of recurrent metastatic lesions is required.\n3. Poor compliance, unable to cooperate and describe treatment responses.\n4. History of past or current central nervous system (CNS) metastasis or leptomeningeal metastasis.\n5. Presence of extrahepatic metastasis.\n6. History of hepatic encephalopathy or liver transplantation.\n7. Clinical symptoms or recurrent pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n8. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational devices within 4 weeks prior to the first dose.\n9. History of or current non-infectious pneumonia or interstitial lung disease requiring systemic corticosteroid therapy.",{"count":54,"type":21},[78],"This study is a single-center, open-label Phase II clinical trial, aiming to enroll approximately 30 unresectable BCLC stage B or C hepatocellular carcinoma (HCC) patients from China. The primary objective is to evaluate the safety and efficacy of AK112 (a dual-specific antibody against PD-1\u002FVEGF) in combination with hepatic arterial infusion chemotherapy (HAIC) for the treatment of unresectable hepatocellular carcinoma.\n\nAll enrolled subjects will receive AK112 (20mg\u002Fkg Q3W) combined with HAIC (utilizing the FOLFOX chemotherapy regimen) until the investigator determines no further clinical benefit (based on RECIST v1.1 imaging evaluation and clinical assessment), intolerable toxicity, completion of 24 months of treatment, or meeting other criteria for treatment discontinuation as outlined in the protocol, whichever occurs first.",[30,27],"2024-04-16",{"date":608,"type":35},"2024-04-19",{"date":610,"type":35},"2024-03-14",{"date":612,"type":21},"2026-06-15",{"name":530,"class":42}]