[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hcc---hepatocellular-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hcc---hepatocellular-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,57,0,25,[9,45,71,99,121,145,169,193,220,241,270,297,316,336,356,376,396,422,447,476,505,524,544,563,582],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100643850","phase-4-sbrt-plus-ql1706-as-second-line-therapy-for-hepatocellular-carcinoma-100643850",false,"NCT07668570","SBRT Plus QL1706 as Second-Line Therapy for Hepatocellular Carcinoma","A Prospective, Single-Arm, Single-Center Exploratory Clinical Study of Stereotactic Body Radiation Therapy Combined With QL1706 in the Second-Line Treatment of Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Male or female patients aged 18 to 75 years, inclusive.\n* Eastern Cooperative Oncology Group performance status score of 0 or 1.\n* Pathologically confirmed hepatocellular carcinoma, based on at least one lesion or previous biopsy confirming hepatocellular carcinoma.\n* Child-Pugh class A, score 5 to 6, or Child-Pugh class B, score 7 only.\n* Barcelona Clinic Liver Cancer stage C or earlier.\n* Not suitable for curative treatment such as surgical resection or liver transplantation, or refusal of curative treatment such as surgical resection or liver transplantation after first-line therapy.\n* At least one measurable lesion confirmed by the investigator according to modified RECIST.\n* All intrahepatic tumor lesions must be considered suitable for stereotactic body radiation therapy by the investigator.\n* At least 700 cc of normal liver volume must be preserved, with a mean radiation dose to this volume of no more than 15 Gy.\n* Received one prior line of systemic therapy and experienced radiographic disease progression or intolerance.\n* Prior local treatment, such as transarterial chemoembolization, hepatic arterial infusion chemotherapy, or radiofrequency ablation, is allowed if the interval between the prior local treatment and initiation of study treatment is at least 28 days.\n* Adequate organ and bone marrow function, defined as all of the following:\n\n  * Hemoglobin at least 9.0 g\u002FdL.\n  * Absolute neutrophil count at least 1.5 × 10\\^9\u002FL or greater than 1500\u002Fmm\\^3.\n  * Platelet count at least 75 × 10\\^9\u002FL or greater than 75,000\u002Fmm\\^3.\n  * Serum bilirubin no more than 1.5 times the institutional upper limit of normal.\n  * Aspartate aminotransferase and alanine aminotransferase no more than 2.5 times the institutional upper limit of normal.\n  * Creatinine clearance greater than 45 mL\u002Fmin, measured directly, calculated by the Cockcroft-Gault formula, or measured by 24-hour urine collection.\n* Female patients of childbearing potential must have a negative urine or serum pregnancy test before the first dose of study treatment.\n* Male or female patients of reproductive potential must agree to use adequate contraception from the first dose of study treatment until 180 days after the last dose of study treatment.\n* Life expectancy of more than 6 months, as assessed by the investigator.\n* Able to understand and comply with study requirements and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Histologically confirmed combined hepatocellular-cholangiocarcinoma, fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or other non-hepatocellular primary liver malignancy.\n* Prior yttrium-90 radioembolization.\n* Hepatitis B viral load greater than 2000 IU\u002FmL despite effective antiviral therapy.\n* More than 3 discrete hepatic nodules.\n* Presence of extrahepatic metastasis or M1 disease.\n* Current participation in another study with investigational treatment, or participation in an investigational drug or device study within 4 weeks before the first dose of study treatment.\n* Immunodeficiency disease, or use of systemic corticosteroids at a daily dose greater than 10 mg prednisone or equivalent on the day of the first dose of study treatment or within 14 days before the first dose of study treatment.\n* Active tuberculosis, or inadequately treated latent tuberculosis infection with a high risk of recurrence in the investigator's judgment.\n* Hypersensitivity to recombinant humanized anti-PD-1 or anti-PD-L1 monoclonal antibodies, recombinant humanized anti-CTLA-4 monoclonal antibodies, or any of their components.\n* Receipt of anticancer therapy within 4 weeks before Day 1 of study treatment, or failure of toxicities from prior therapy to recover to Grade 1 or lower or to baseline level.\n* Other progressive malignancy requiring active treatment.\n* Autoimmune disease requiring systemic treatment within the past 2 years, including immunomodulators, corticosteroids, or immunosuppressants. Replacement therapy such as thyroxine, insulin, or physiologic hormone replacement for adrenal or pituitary insufficiency is not considered systemic treatment. Prior organ transplantation, including liver transplantation.\n* History or evidence of active non-infectious pneumonitis.\n* Active infection requiring systemic therapy.\n* Psychiatric illness or history of substance abuse that may interfere with study compliance.\n* Receipt of a live vaccine within 30 days before the planned initiation of study treatment.\n* Planned pregnancy or breastfeeding.\n* Any medical history, treatment, or laboratory abnormality that, in the investigator's judgment, may interfere with study results, affect full participation in the study, or not be in the patient's best interest.","ALL","18 Years","75 Years",{"count":21,"type":22},36,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","This is a prospective, single-arm, single-center exploratory clinical study designed to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) combined with QL1706 in patients with hepatocellular carcinoma who have received one prior line of systemic therapy and experienced radiographic disease progression or intolerance.\n\nEligible patients will receive SBRT to all evaluable intrahepatic lesions at a total dose of 25-50 Gy delivered in 5 fractions. Within 7-14 days after completion of SBRT, patients will receive QL1706 at 7.5 mg\u002Fkg by intravenous infusion every 3 weeks. Treatment with QL1706 will continue until confirmed disease progression, intolerable toxicity, patient request to withdraw, withdrawal of informed consent, or other protocol-defined treatment discontinuation criteria, whichever occurs first.\n\nThe primary endpoint is objective response rate assessed by the investigator according to modified RECIST criteria. Secondary endpoints include local control rate of SBRT target lesions, progression-free survival, overall survival, disease control rate, and the incidence of adverse events and serious adverse events. Exploratory endpoints include dynamic changes in serum tumor biomarkers and immune-related indicators, as well as their association with clinical outcomes. A total of 36 patients are planned for enrollment.",[28],"HCC - Hepatocellular Carcinoma",[30,31,32],"Hepatocellular carcinoma","second-line","SBRT","NOT_YET_RECRUITING","2026-06-21",{"date":36,"type":37},"2026-06-25","ACTUAL",{"date":39,"type":22},"2026-07",{"date":41,"type":22},"2030-07",{"name":43,"class":44},"Hebei Medical University Fourth Hospital","OTHER",{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100619980","a-multicenter-prospective-study-on-the-performance-of-spectral-ct-for-evaluating-treatment-response-after-tace-in-hepatocellular-carcinoma-100619980","NCT07351669","A Multicenter Prospective Study on the Performance of Spectral CT for Evaluating Treatment Response After TACE in Hepatocellular Carcinoma","The Performance of Spectral CT in Evaluating Treatment Response After Transarterial Chemoembolization for Hepatocellular Carcinoma: The SpecTRAIL Study","Inclusion Criteria:\n\n1. age 18-75 years;\n2. diagnosis of HCC based on pathological findings or accepted clinical and imaging criteria;\n3. Barcelona Clinic Liver Cancer (BCLC) stage A or B;\n4. prior treatment with TACE;\n5. undergoing contrast-enhanced spectral CT at 4-8 weeks after TACE;\n6. undergoing either liver resection within 1 week after contrast-enhanced spectral CT (surgical cohort) or undergoing hepatic digital subtraction angiography (DSA) or contrast-enhanced MRI within 1 week after contrast-enhanced spectral CT (non-surgical cohort);\n7. informed consent.\n\nExclusion Criteria:\n\n1. contraindications to contrast-enhanced CT or MRI;\n2. presence of extrahepatic malignancy;\n3. poor image quality or incomplete clinical data;\n4. lack of regular CT or MRI follow-up in non-surgical cohort;\n5. withdrawal from the study.",{"count":53,"type":22},121,"1 Year","OBSERVATIONAL","By comparing the diagnostic accuracy of spectral CT and conventional CT in evaluating treatment response efficacy after TACE, this study aims to investigate the diagnostic performance of spectral CT in assessing treatment response following TACE for hepatocellular carcinoma.",[28,58,59],"TACE(Transcatheter Arterial Chemoembolization)","CT","RECRUITING","2026-06-09",{"date":63,"type":37},"2026-06-10",{"date":65,"type":37},"2026-01-20",{"date":67,"type":22},"2028-06-30",{"name":69,"class":44},"Zhongda Hospital",1,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":70},"100635840","phase-2-epalrestat-combined-with-haic-donafenib-and-tislelizumab-as-first-line-treatment-for-patients-with-unresectable-hcc-and-diabetes-100635840","NCT07557914","Epalrestat Combined With HAIC, Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable HCC and Diabetes","A Multicenter, Prospective, Single-arm Clinical Study Evaluating the Efficacy and Safety of Epalrestat Combined With Hepatic Arterial Chemotherapy Infusion (HAIC), Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable Hepatocellular Carcinoma and Diabetes","Inclusion Criteria:\n\n1. Diabetes mellitus combined with unresectable advanced HCC (BCLC stage C);\n2. Patients who have the need for treatment, prevention and improvement of diabetic neuropathy;\n3. Liver function at Child-Pugh grade A or B (≤ 7 points), ECOG PS 0-1;\n4. Age 18-80 years old. Confirmed as unrectable HCC through pathological or imaging diagnosis;\n\nExclusion Criteria:\n\n1. Severe liver dysfunction: Child-Pugh C grade (≥ 8 points) or active hepatic encephalopathy Illness;\n2. Extensive extrahepatic metastases (e.g., lung, bone, or peritoneum metastases);\n3. Severe cardiovascular diseases: Uncontrolled heart failure, recent myocardial infarction;\n4. Renal failure: Creatinine clearance rate \\\u003C 30 mL\u002Fmin;\n5. Thrombocytopenia (less than 50×10⁹\u002FL) or coagulation dysfunction (INR greater than 1.5);\n6. Active infection (such as uncontrolled hepatitis B virus replication with HBV-DNA \\> 2000 IU\u002FmL);\n7. ECOG PS ≥ 2 or extremely poor overall condition;\n8. Diabetic patients with acute ketoacidosis or during the period of severe infection;\n9. Pregnant and lactating women;\n10. Known history of other malignancy.","80 Years",{"count":80,"type":22},32,[82],"PHASE2","The purpose of this study is to evaluate the comprehensive therapeutic efficacy and safety profile of the epalrestat combined with hepatic artery infusion chemotherapy (HAIC), donafenib and tislelizumab quadruple regimen in patients with unresectable hepatocellular carcinoma (HCC) and diabetes.",[28,85],"Diabetes",[87,88,89,28,85],"hepatic arterial infusion chemotherapy","Donafenib","Tislelizumab","2026-06-01",{"date":92,"type":37},"2026-06-03",{"date":94,"type":22},"2026-06",{"date":96,"type":22},"2029-02",{"name":98,"class":44},"Haibo Shao",{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100638921","a-multicenter-randomized-open-label-controlled-study-of-haic-combined-with-camrelizumab-and-apatinib-mesylate-for-perioperative-treatment-of-resectable-hepatocellular-carcinoma-with-high-risk-recurrence-factors-100638921","NCT07618546","A Multicenter, Randomized, Open-label, Controlled Study of HAIC Combined With Camrelizumab and Apatinib Mesylate for Perioperative Treatment of Resectable Hepatocellular Carcinoma With High-risk Recurrence Factors","Inclusion Criteria:\n\n* 1: 1. Age 18-80, both male and female are acceptable;\n\n  2: 2. Hepatocellular carcinoma (HCC) confirmed by histopathology, cytology, or imaging, with CNLC staging of Ia-IIIa, excluding patients with stage IIIa HCC combined with main portal vein tumor thrombus;\n\n  3: 3. Meets the indications for radical surgical resection;\n\n  4: 4. There are clearly defined high-risk recurrence factors (tumor diameter \\>5 cm, microvascular invasion, satellite lesions, incomplete tumor capsule, alpha-fetoprotein \\>400 μg\u002FL, etc.;\n\n  5: 5. ECOG: 0-1;\n\n  6: 6. The functions of major organs have been assessed and meet the requirements for the study treatment;\n\n  7: 7. Has not previously received systematic treatment.\n\n  8: 8. Expected survival time ≥ 12 weeks;\n\n  9: 9. Baseline blood cell count tests and blood biochemistry must meet the following criteria: white blood cell count ≥ 3.0 × 10\\^9\u002FL; hemoglobin ≥ 90 g\u002FL; absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL; platelet count ≥ 75 × 10\\^9\u002FL; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN); total bilirubin ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; albumin ≥ 30 g\u002FL;\n\n  10: 10. Women of childbearing age must agree to use contraception (such as intrauterine devices, contraceptive pills, or condoms) during the study period and for 6 months after the end of the study; they must have a negative serum or urine pregnancy test within 7 days prior to enrollment in the study and must not be breastfeeding. Men must agree to use contraception during the study period and for 6 months after the study ends.\n\n  11: 11. The subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n* 1: 1. Merge distant metastases;\n\n  2: 2. Those allergic to camrelizumab and apatinib mesylate;\n\n  3: 3. Previously received systemic or local treatment for liver cancer;\n\n  4: 4. Pleural effusion, pericardial effusion, or ascites accompanied by clinical symptoms and judged by the investigator to require frequent drainage;\n\n  5: 5. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);\n\n  6: 6. Active or uncontrolled serious infections (≥CTCAE5.0 grade 2 infection), including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia, and unexplained fever \\>38.5°C before the first dose;\n\n  7: 7. Those with a history of abuse of psychotropic drugs who are unable to quit, or who have mental disorders;\n\n  8: 8.5 Subjects who have had or currently have other malignant tumors requiring active treatment (excluding those that have been adequately treated, such as basal cell or squamous cell skin cancer with an expected 5-year survival rate \\>90%, carcinoma in situ of the cervix, or carcinoma in situ of the breast);\n\n  9: 9. Presence of uncorrectable coagulation disorders;\n\n  10: 10. Cardiovascular diseases with significant clinical relevance, including but not limited to acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass surgery within 6 months prior to enrollment; congestive heart failure New York Heart Association (NYHA) class ≥ 2; ventricular arrhythmias requiring medication (including QTc interval ≥ 450 ms for males, ≥ 470 ms for females); left ventricular ejection fraction (LVEF) \\\u003C50%;\n\n  11: 11. Severe liver disease (such as cirrhosis), kidney disease, respiratory system diseases, uncontrolled diabetes, or other types of systemic diseases.\n\n  12: 12. Imaging shows that the tumor has invaded major blood vessels, or the researcher judges that during subsequent studies, the tumor is highly likely to invade major blood vessels and cause fatal massive bleeding;\n\n  13: 13. Patients with active autoimmune diseases or immunodeficiency, or with the following medical history, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc., shall not be included. Exceptions are as follows: patients with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy may be eligible for the study. Patients with type 1 diabetes whose blood glucose is controlled after insulin therapy may participate in this study.\n\n  14: 14. The patient is using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose \\>10mg\u002Fday of prednisone or other equivalent steroids, and still using within 2 weeks prior to enrollment);\n\n  15: 15. Experienced arterial\u002Fvenous thrombotic events within 6 months before the first administration, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, and pulmonary embolism;\n\n  16: 16. The investigator assesses digestive tract diseases or conditions that may affect drug absorption, including but not limited to active gastric and duodenal ulcers, ulcerative colitis, or incompletely resected gastrointestinal tumors with active bleeding, or other conditions deemed by the investigator that may cause gastrointestinal bleeding or perforation, and those with multiple factors affecting oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction).\n\n  17: 17. Hypertension not adequately controlled by medication is defined as: systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>100 mmHg;\n\n  18: 18. Underwent surgery (excluding biopsy) within 28 days before being enrolled in this study, or the surgical incision has not completely healed;\n\n  19: 19. Received any other investigational drug treatment or participated in other interventional studies within 4 weeks prior to signing the informed consent form;\n\n  20: 20. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;\n\n  21: 21. According to the researcher's judgment, the patient is considered not suitable for enrollment.",{"count":106,"type":22},208,[108],"NA","This study aims to explore the value of the 'HAIC Apatinib Camrelizumab' triple regimen for perioperative treatment of resectable hepatocellular carcinoma. The study adopts a multicenter, randomized, open-label, controlled design and plans to enroll 208 patients, randomly assigned 1:1 to the experimental group and the control group. The experimental group will receive preoperative HAIC combined with targeted-immunotherapy triple regimen neoadjuvant therapy, followed by radical resection, and continue postoperative adjuvant therapy; the control group will undergo surgery directly. The primary endpoint is EFS, and secondary endpoints include R0 resection rate, pCR, MPR, OS, and 1-year\u002F2-year\u002F3-year EFS rates.",[28],[112],"HCC","2026-05-25",{"date":90,"type":37},{"date":113,"type":22},{"date":117,"type":22},"2028-03-31",{"name":119,"class":120},"Henan Cancer Hospital","OTHER_GOV",{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":70},"100639119","efficacy-and-safety-of-sirt-y90-in-combination-with-atezo--bev-for-unresectable-hepatocellular-carcinoma-100639119","NCT07610551","Efficacy and Safety of SIRT-Y90 in Combination With Atezo + Bev for Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Age ≥18 years old A diagnosis of unresectable HCC was made. HCC can be diagnosed clinically or pathologically.\n\nAt least one Atezo plus Bev administration and one cycle of SIRT-Y90 treatment. At least one visit was recorded after the initiation of Atezo + Bev and SIRT-Y90\n\nExclusion Criteria:\n\n* Concomitant cancers other than BCC were diagnosed before or at the start of Atezo + Bev or SIRT-Y90 Participate in an interventional clinical study before or at the time of initiation of treatment with Atezo + Bev or SIRT-Y90",{"count":128,"type":22},50,"This study adopted a bidirectional cohort study design. On the one hand, the previous clinical data, treatment exposure and clinical endpoint events of the enrolled patients were retrospectively collected. On the other hand, prospective regular follow-up was conducted from the date of enrollment to continuously observe long-term recurrence, progression and survival outcomes, and analyze the correlation between related factors and prognosis. The primary objective of this study was to describe the efficacy and safety of SIRT-Y90 in combination with atezolizumab and bevacizumab in adult patients with unresectable HCC in China. Medical records from approximately eight sites in China will be used.",[28],[132,133,134,135],"Hepatocellular Carcinoma","SIRT-Y90","Atezolizumab","Bevacizumab","2026-05-20",{"date":138,"type":37},"2026-05-28",{"date":140,"type":37},"2022-02-09",{"date":142,"type":22},"2026-12-31",{"name":144,"class":44},"Air Force Military Medical University, China",{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":165,"leadSponsor":167,"locationsCount":4},"100637742","phase-2-the-dohaics-study-expansion-phase-100637742","NCT07584018","The DoHAICs Study Expansion Phase","Clinical Study on the Efficacy and Safety of Donafenib Combined With Hepatic Artery Infusion Chemotherapy and Sintilimab as the First-line Treatment for Unresectable Hepatocellular Carcinoma - the DoHAICs Study Expansion Phase","Inclusion Criteria:\n\n* Voluntarily participate in the trial and provide written informed consent.\n* Age between 18 and 80 years (inclusive), regardless of gender.\n* Patients with hepatocellular carcinoma (HCC) clinically diagnosed per the \"Standard for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)\" or confirmed by histology\u002Fcytology.\n* Patients with inoperable or metastatic hepatocellular carcinoma.\n* No prior systemic therapy for advanced disease. Patients who received adjuvant chemotherapy following local therapy are eligible if chemotherapy was completed \\>12 months ago and disease progression or metastasis has occurred.\n* Completion of the last interventional therapy, radiotherapy, or ablation therapy \\>4 weeks prior.\n* For patients with prior hepatectomy, resection must have been R0, and tumor recurrence must have occurred more than 24 months after surgery.\n* At least one measurable lesion as defined by RECIST 1.1 criteria.\n* Life expectancy ≥3 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Child-Pugh score ≤7.\n* Able and willing to comply with the protocol for the observation of adverse events and efficacy.\n* Adequate organ function, defined as meeting the following criteria:\n* Hematological function (without transfusion or granulocyte colony-stimulating factor \\[G-CSF\\] support within 14 days prior to screening):\n* Hemoglobin ≥90 g\u002FL.\n* Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL.\n* Platelet count ≥75 × 10⁹\u002FL.\n* Biochemical tests (without albumin infusion within 14 days prior to screening):\n* Albumin ≥28 g\u002FL.\n* Total bilirubin ≤2 × upper limit of normal (ULN).\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 × ULN.\n* Alkaline phosphatase (ALP) ≤5 × ULN.\n* Serum creatinine ≤1.5 × ULN.\n* Coagulation function:\n* International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN.\n* Activated partial thromboplastin time (APTT) ≤1.5 × ULN.\n\nExclusion Criteria:\n\n* Histologically\u002Fcytologically confirmed components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma.\n* History of malignancies other than hepatocellular carcinoma, except under the following circumstances:\n* The patient has undergone potentially curative treatment with no evidence of that disease for 5 years.\n* Successfully resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other carcinoma in situ.\n* Diffuse tumor lesions.\n* History of hepatic encephalopathy, hepatorenal syndrome, or liver transplantation.\n* Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage.\n* Central nervous system metastases.\n* History of severe psychiatric illness.\n* Diseases affecting the absorption, distribution, metabolism, or excretion of the investigational drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.).\n* Prior allogeneic stem cell or solid organ transplantation.\n* Prior treatment with anti-VEGF\u002FVEGFR, RAF, MEK pathway targeted therapies (e.g., sorafenib, lenvatinib, regorafenib) or immunomodulators (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies).\n* Prior other systemic anti-tumor therapy, including Chinese herbal medicine with anti-tumor indications, completed less than 2 weeks before study drug initiation; or patients with adverse events from prior therapy not recovered to ≤ Grade 1 per CTCAE (excluding alopecia and Grade 1\u002F2 neuropathy caused by oxaliplatin).\n* Concurrent use of medications known to prolong QTc interval and\u002For induce Torsades de Pointes (TdP), or medications that affect drug metabolism.\n* Past or present congenital or acquired immunodeficiency diseases.\n* Active or history of autoimmune or inflammatory diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, hypophysitis, hyper- or hypothyroidism, asthma requiring bronchodilators, etc.). Patients with vitiligo or asthma that was fully resolved in childhood and requires no intervention in adulthood may be included.\n* Use of systemic immunosuppressive medication within 2 weeks prior to enrollment, or anticipated requirement for such medication during the study, except for:\n* Intranasal, inhaled, topical, or local corticosteroid injections (e.g., intra-articular).\n* Systemic corticosteroids at physiological doses not exceeding 10 mg\u002Fday prednisone or equivalent.\n* Prophylactic use of corticosteroids for hypersensitivity reactions.\n* Known or suspected hypersensitivity to donafenib, drugs of the same class, or history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergy to any excipient of the investigational drug.\n* Active bleeding or coagulation disorders, bleeding tendency, or undergoing thrombolytic, anticoagulant, or antiplatelet therapy.\n* Thrombotic or thromboembolic events within the past 6 months, such as stroke and\u002For transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc.\n* History of esophageal or gastric variceal bleeding due to portal hypertension within the past 6 months, or any life-threatening bleeding event within the past 3 months.\n* Significant cardiovascular disease, including but not limited to: acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within the past 6 months; congestive heart failure (NYHA class \\>2); poorly controlled arrhythmias requiring pacemaker treatment; uncontrolled hypertension (systolic BP ≥140 mmHg and\u002For diastolic BP ≥90 mmHg).\n* Other clinically significant abnormalities, deemed by the investigator to affect safety evaluation, such as uncontrolled diabetes, chronic kidney disease, Grade II or higher peripheral neuropathy (CTCAE v6.0), abnormal thyroid function, etc.\n* Active or poorly controlled severe infection; active infections including:\n* Positive for Human Immunodeficiency Virus (HIV) (HIV1\u002F2 antibodies).\n* Active Hepatitis B (HBsAg positive or HBV DNA \\>2000 IU\u002FmL with abnormal liver function).\n* Active Hepatitis C (HCV antibody positive or HCV RNA ≥10³ copies\u002FmL with abnormal liver function).\n* Active tuberculosis.\n* Other uncontrolled active infections (CTCAE v6.0 \\> Grade 2).\n* Incomplete recovery from surgery, such as unhealed wounds or severe postoperative complications.\n* Pregnancy, lactation, or patients of childbearing potential unwilling or unable to use effective contraception.",{"count":153,"type":22},90,[82],"We explored the efficacy and safety of the first-line treatment of unresectable hepatocellular carcinoma with donafenib combined with hepatic artery infusion chemotherapy (HAIC) and sintilimab .",[28],[158,159,160],"Hepatocellular carcinoma;","Hepatic artery infusion chemotherapy","Surgical resection","2026-05-07",{"date":163,"type":37},"2026-05-13",{"date":136,"type":22},{"date":166,"type":22},"2027-06-01",{"name":168,"class":44},"Tianjin Medical University Cancer Institute and Hospital",{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":23,"phases":179,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":70},"100638934","phase-2-defining-the-ablative-dose-for-y-90-tare-100638934","NCT07586046","Defining the Ablative Dose for Y-90 TARE","A Prospective Dose-Escalation Study to Define an Ablative Dose of Yttrium-90 Transarterial Radioembolization Using Advanced Dosimetry and Functional MRI (MARGIN Study)","MARGIN","Inclusion Criteria:\n\n* Diagnosis of hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver-dominant metastatic disease not amenable to surgical resection or ablation.\n* Age ≥18 years.\n* Tumor size ≤5 cm requiring treatment of ≤2 Couinaud segments.\n* Child-Pugh class A or B liver function\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Adequate organ and bone marrow function as defined below:\n* Leukocytes (WBC) ≥ 3,000\u002FmcL\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL\n* Hemoglobin ≥ 9 g\u002FdL\n* Platelets ≥ 50,000\u002FmcL\n* Total bilirubin ≤ 3.0 mg\u002FdL\n* AST ≤ 100 U\u002FL, ALT ≤ 120 U\u002FL\n* Creatinine ≤ 2.0 mg\u002FdL or estimated GFR ≥ 40 mL\u002Fmin\u002F1.73 m²\n* Ability to undergo imaging and laboratory evaluations required by the study.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Extrahepatic metastases.\n* Pregnant or breastfeeding individuals.\n* Tumors requiring treatment of more than two Couinaud segments.\n* Known hypersensitivity to gadolinium-based contrast agents.\n* Contraindications to MRI (e.g., incompatible pacemakers, claustrophobia unresponsive to sedation).\n* Coagulopathy or clinical instability precluding angiographic intervention.\n* Prisoners or individuals under legal custody.\n* Adults unable to consent.\n* Individuals under 18 years of age.",{"count":178,"type":22},30,[82],"This study is being done to help doctors improve how they treat liver tumors that cannot be removed by surgery or treated with standard ablation techniques. The researchers want to find out the best amount of radiation that needs to be delivered to completely destroy (or ablate) parts of the liver that have cancer.",[28],[175,112,183,184],"Y90","Liver Cancer",{"date":186,"type":37},"2026-05-14",{"date":188,"type":22},"2026-05",{"date":190,"type":22},"2029-05",{"name":192,"class":44},"Northwestern University",{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":202,"briefSummary":203,"conditions":204,"keywords":205,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":215,"leadSponsor":217,"locationsCount":219},"100636651","social-determinants-of-health-hcc-trial-100636651","NCT07568457","Social Determinants of Health HCC Trial","A Randomized Controlled Interventional Trial of a Social Determinants of Health and Patient Navigation Program to Improve Treatment Utilization Among Low-income Patients With Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Adults (18 years or older)\n* Diagnosis of HCC (BCLC Stage A-C)\n* Uninsured or underinsured (i.e., Medicaid as primary or secondary insurance)\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Non-HCC liver tumors\n* BCLC Stage D and\u002For Child Pugh C cirrhosis (latter unable to receive treatment due to poor liver function)\n* No plans for cancer treatment for any reason including patient refusal (best supportive care only)\n* Only oral systemic therapy planned (i.e., tyrosine kinase inhibitors)\n* Incarcerated patients or pregnant patients\n* Unable to provide informed consent",{"count":201,"type":22},75,[108],"The goal of this study is to test whether providing various social resources (transportation support through Lyft rides, housing support through Hyatt House LA, and meal support through Project Angel Food LA) will reduce treatment delays and increase treatment uptake for patients with liver cancer.",[28],[112,206,207,208,209,210],"Social Determinants of Health","SDOH","health services","interventional trial","transportation","2026-04-30",{"date":213,"type":37},"2026-05-05",{"date":94,"type":22},{"date":216,"type":22},"2028-09",{"name":218,"class":44},"University of Southern California",3,{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":70},"100636038","phase-2-ipilimumab-n01-combined-with-sintilimab-bevacizumab-biosimilar-and-hepatic-arterial-infusion-chemotherapy-as-conversion-therapy-for-unresectable-intermediate-advanced-hepatocellular-carcinoma-100636038","NCT07560488","Ipilimumab N01 Combined With Sintilimab, Bevacizumab Biosimilar, and Hepatic Arterial Infusion Chemotherapy as Conversion Therapy for Unresectable Intermediate-Advanced Hepatocellular Carcinoma","Conversion Therapy With Ipilimumab N01 Combined With Sintilimab, Bevacizumab Biosimilar, and Hepatic Arterial Infusion Chemotherapy for Unresectable Intermediate-Advanced Hepatocellular Carcinoma: A Prospective, Single-Arm Phase II Study","Inclusion Criteria:\n\n* Written informed consent must be signed prior to initiation of any study-related procedures;\n* Age ≥ 18 years, and ≤75 years, regardless of gender;\n* Clinically diagnosed or histologically\u002Fcytologically confirmed hepatocellular carcinoma (HCC) according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition);\n* No prior anti-tumor therapy for HCC before study treatment\n* Unresectable locally advanced or advanced HCC (CNLC Stage IIa-IIIb).\n* Expected overall survival \\> 6 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Child-Pugh score class A or B\n* Adequate organ function defined by the following laboratory parameters:\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL without granulocyte colony-stimulating factor support within 14 days;\n  2. Platelet count ≥ 80×10⁹\u002FL without transfusion within 14 days;\n  3. Hemoglobin \\> 9 g\u002FdL without transfusion or erythropoietin within 14 days;\n  4. Total bilirubin ≤ 1.5×upper limit of normal (ULN); or total bilirubin \\> ULN with direct bilirubin ≤ ULN;\n  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3×ULN;\n  6. Serum creatinine ≤ 1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 mL\u002Fmin;\n  7. Adequate coagulation function defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN;\n  8. Normal thyroid function defined as thyroid-stimulating hormone (TSH) within normal limits. Subjects with abnormal baseline TSH but normal total T3 (or FT3) and FT4 are also eligible;\n  9. Myocardial enzymes within normal limits; isolated laboratory abnormalities deemed clinically insignificant by the investigator are permitted.\n* Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first dose of study drug (Day 1 of Cycle 1). A blood pregnancy test is required if the urine test is inconclusive; They must agree to use adequate contraception during the study period and for 8 weeks after the last dose of study drug;\n* All subjects (male or female) of reproductive potential must use a highly effective contraceptive method with an annual failure rate \\\u003C 1% throughout treatment and for 120 days after the last dose of immunotherapy or 180 days after the last dose of chemotherapy, whichever is longer.\n\nExclusion Criteria:\n\n* Target disease exceptions:\n\n  1. Fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma.\n  2. Recurrent HCC.\n  3. Clinically diagnosed hepatic encephalopathy within the most recent 6 months.\n* Autoimmune hepatitis (requiring liver biopsy confirmation);\n* History of organ transplantation or history of hepatic encephalopathy;\n* Diffuse hepatocellular carcinoma;\n* Symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage;\n* History of any renal disease or nephrotic syndrome.\n* Variceal bleeding (esophageal or gastric varices) due to portal hypertension within the past 6 months;severe (Grade 3) varices on endoscopy within 3 months before first dose;evidence of portal hypertension (e.g., splenomegaly \\>10 cm in longest diameter with platelets \\\u003C100×10⁹\u002FL on imaging) with high bleeding risk as assessed by the investigator;\n* Arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other severe thromboembolism.Excluded are catheter-related or port-related thrombosis or superficial venous thrombosis that is stable with standard anticoagulation;\n* Severe bleeding tendency or coagulopathy, or ongoing thrombolytic therapy;\n* Prophylactic low-molecular-weight heparin (e.g., enoxaparin 40 mg daily) is permitted; vitamin K antagonists (e.g., warfarin) are excluded;\n* Long-term use of anti-platelet agents including aspirin, dipyridamole, clopidogrel, or other similar medications;\n* Uncontrolled hypertension despite optimal medical management (systolic BP \\>140 mmHg or diastolic BP \\>90 mmHg); history of hypertensive crisis or hypertensive encephalopathy;\n* Symptomatic congestive heart failure (NYHA Class II-IV); symptomatic or poorly controlled arrhythmia; congenital long QT syndrome or QTcF \\>500 ms at screening;\n* History of gastrointestinal perforation and\u002For fistula within the past 6 months; history of bowel obstruction (including partial obstruction requiring parenteral nutrition); extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea;\n* Major surgical procedure (cranial, thoracic, or abdominal) within 4 weeks before first dose, or non-healing wounds, ulcers, or fractures.Core needle biopsy or minor surgery within 7 days before first dose is excluded, except for venous catheter placement for intravenous access;\n* History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonitis, or severe pulmonary dysfunction;\n* Acute or chronic active hepatitis B or C infection:HBV DNA \\>2000 IU\u002FmL or 10⁴ copies\u002FmL;HCV RNA \\>10³ copies\u002FmL;coinfection with HBsAg and anti-HCV antibody;\n* Active tuberculosis (TB), ongoing anti-TB treatment, or anti-TB treatment within 1 year before first dose;\n* Human immunodeficiency virus (HIV) infection (positive HIV 1\u002F2 antibody) or active syphilis;\n* Active or poorly controlled severe infection; severe infection requiring hospitalization (including sepsis, bacteremia, or severe pneumonia) within 4 weeks before first dose;\n* Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years before first dose.Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal\u002Fpituitary insufficiency) is permitted.History of primary immunodeficiency.Subjects with isolated positive autoimmune antibodies will be evaluated at the investigator's discretion;\n* Systemic immunosuppressive drugs within 4 weeks before first dose, excluding topical, inhaled, or intranasal corticosteroids or physiological systemic corticosteroids (≤10 mg\u002Fday prednisone or equivalent).Temporary corticosteroids for acute dyspnea in asthma or COPD are permitted;\n* Live attenuated vaccine within 4 weeks before first dose or planned use during the study period;\n* Chinese herbal medicine with anti-tumor indications, or immunomodulatory agents (including thymosin, interferon, interleukin) within 2 weeks before first dose, except for local administration for pleural effusion or ascites;\n* Uncontrolled or irreversible metabolic disorders, other acute or chronic non-malignant organ diseases, systemic illnesses, or paraneoplastic syndromes that may increase medical risk or confound survival assessment;\n* Diagnosis of another malignancy within 5 years before first dose, except for radically treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ.For other malignancies diagnosed \\>5 years before enrollment, pathological or cytological confirmation of recurrent\u002Fmetastatic lesions is required;\n* Prior treatment with anti-PD-1, anti-PD-L1\u002FL2, anti-CTLA-4 antibodies, or other immune checkpoint inhibitors;\n* Known hypersensitivity to sintilimab, bevacizumab, ipilimumab N01 or their excipients, or severe hypersensitivity to other monoclonal antibodies;\n* Participation in another interventional clinical trial within 4 weeks before first dose;\n* Female subjects who are pregnant or breastfeeding;\n* Any other acute or chronic diseases, psychiatric disorders, or abnormal laboratory values that may increase risks associated with study participation or study drug administration, or interfere with the interpretation of study results, and that, in the investigator's judgment, render the patient ineligible for participation in this study.",{"count":228,"type":22},43,[82],"Conversion therapy for unresectable intermediate-advanced hepatocellular carcinoma (uHCC) has evolved from systemic therapy to combined local-systemic approaches, but current regimens still have limited surgical conversion rates.\n\nThis prospective, single-arm phase II study evaluates a combination regimen of PD-1 inhibitor (sintilimab) plus CTLA-4 inhibitor (ipilimumab N01), bevacizumab biosimilar, and HAIC for patients with initially unresectable intermediate-advanced HCC. The primary goal is to achieve a higher surgical conversion rate with manageable safety",[28,232],"Conversion Therapy","2026-04-27",{"date":235,"type":37},"2026-05-01",{"date":237,"type":37},"2026-03-30",{"date":239,"type":22},"2028-04",{"name":168,"class":44},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":23,"phases":250,"briefSummary":251,"conditions":252,"keywords":253,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":70},"100633066","phase-2-a-phase-iia-single-arm-open-label-clinical-study-to-evaluate-the-efficacy-safety-and-pk-of-cvm-1118-in-combination-with-sintilimab-and-tace-in-participants-with-incurablenon-metastatic-hcc-100633066","NCT07521852","A Phase IIa, Single-arm, Open-label Clinical Study to Evaluate the Efficacy, Safety and PK of CVM-1118 in Combination With Sintilimab and TACE in Participants With Incurable\u002FNon-metastatic HCC","A Phase IIa, Single-arm, Open-label Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetic (PK) of CVM-1118 in Combination With Sintilimab and Transarterial Chemoembolization (TACE) in Participants With Incurable\u002FNon-metastatic Hepatocellular Carcinoma","Inclusion Criteria:\n\n* 1\\) Participant is ≥18 years of age, at the time of providing the documented informed consent.\n\n  2\\) Diagnosis of hepatocellular carcinoma\n  * Pathologically or cytologically-confirmed or clinically diagnosed in accordance with American Association for the Study of Liver Diseases (AASLD) criteria (i.e., radiologic imaging with cross-sectional multiphasic contrast computed tomography \\[CT\\] or magnetic resonance imaging \\[MRI\\] showing a ≥ 1 cm liver lesion).\n\n    3\\) No evidence of extrahepatic disease on any available imaging. 4) Disease not amenable to curative surgery or transplantation or curative ablation.\n\n    5\\) Disease must be amenable to TACE and anticipated to require no more than 4 TACE treatments for local disease sites, with a maximum of 2 TACE treatments per individual lesion .\n\n    6\\) Child-Pugh liver function class A (see Appendix 2). 7) At least one measurable (per RECIST 1.1) lesion (see Appendix 1). 8) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (see Appendix 3).\n\n    9\\) Patients with hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (anti-HBcAb) positive, and HBV DNA detected positive (≥10 IU\u002Fml or above the local laboratory's standard detection limit), who have stable disease or show antiviral response (e.g., reduction in HBV DNA levels) after treatment, and agree to receive treatment during the trial, shall be allowed to enroll.\n\n    10\\) Patients with hepatitis C virus (HCV) infection who agree to receive treatment during the trial are eligible for enrollment.\n\n    11\\) Participants must have adequate organ and bone marrow function, meeting the following laboratory criteria:\n  * Hematology: Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL; Platelet count (PLT) ≥75 × 10⁹\u002FL; Hemoglobin (HGB) ≥9.0 g\u002FdL without transfusion or erythropoietin (EPO) dependency\n  * Liver Function: Total bilirubin (T-Bil) ≤2 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN; Serum albumin ≥30 g\u002FL\n  * Renal Function: Non-indexed eGFR ≥ 60 mL\u002Fmin (formula in Appendix 4)\n  * Coagulation: International normalized ratio (INR) ≤2 × ULN; prothrombin time (PT) ≤1.5 × ULN 12) Life expectancy of ≥12 weeks. 13) Male and female participants of childbearing potential must agree to use effective contraception from the signing of the informed consent form (ICF) until 6 months after the last dose of the investigational product. Female participants of childbearing potential are defined as premenopausal women. A negative pregnancy test result must be confirmed for all female of childbearing potential within ≤7 days prior to the first dose of the investigational product.\n\n    14\\) Signed written informed consent form and ability to comply with protocol-specified visits and related procedures.\n\nExclusion Criteria:\n\n* 1\\) Known hypersensitivity to CVM-1118, Sintilimab components, or severe allergic reactions to monoclonal antibodies.\n\n  2\\) Histologically\u002Fcytologically confirmed components of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.\n\n  3\\) Has HCC lesions occupying ≥50% of the liver volume. 4) Major portal vein tumor thrombosis involving the main trunk and its first-order branches (i.e., Vp3 and Vp4), as demonstrated by imaging performed during the screening period.\n\n  5\\) Is currently a candidate for liver transplantation. 6) Receipt of anti- programmed cell death protein 1 (PD-1), anti- programmed death - ligand 1 (PD-L1), or anti - programmed death - ligand 2 (PD-L2) agent or an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., Cytotoxic T - lymphocyte - associated protein 4 \\[CTLA-4\\]).\n\n  7\\) Receipt of locoregional therapy to existing liver lesions (such as TACE, transcatheter arterial embolization \\[TAE\\], transarterial radioembolization (TARE), hepatic arterial infusion, or radiation,) for treatment of HCC. Use of TACE or TAE as part of a curative therapy (e.g., in conjunction with ablation or surgery) can be acceptable if it is used in the lesions where curative therapy was attempted. However, TACE or TAE cannot have been used as sole modalities in prior curative therapy.\n\n  8\\) Receipt of prior systemic anticancer therapies for HCC. 9) History of abdominal fistula or gastrointestinal (GI) perforation, non-healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment.\n\n  10\\) Has bleeding or thrombotic disorders or is using anticoagulants requiring therapeutic INR monitoring, e.g., warfarin or similar agents. Treatment with antiplatelet agents and low molecular weight heparin is permitted.\n\n  11\\) Has clinically apparent ascites on physical examination that is not controlled with medication.\n\nNote: Ascites detectable on imaging studies only are allowed 12) Has had clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to therapy. Participants on rifaximin or lactulose during screening to control their hepatic encephalopathy are excluded.\n\n13\\) Has medical contraindications that preclude all forms of contrast enhanced imaging (CT or MRI).\n\n14\\) Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of CVM-1118.\n\n15\\) Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula.\n\n16\\) Has clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior to the first dose of investigational product.\n\n17\\) Has significant cardiovascular impairment within 12 months of the first dose of investigational product such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II (Appendix 5), unstable angina, myocardial infarction or cerebrovascular accident stroke, or cardiac arrhythmia associated with hemodynamic instability.\n\n18\\) Has had major surgery to the liver within 4 weeks prior to the first dose of investigational product.\n\nNote: If participant underwent major surgery, they must have adequately recovered from the toxicity and\u002For complications from the intervention prior to starting investigational product.\n\n19\\) Has had a minor surgery within 7 days prior to the first dose of investigational product.\n\n20\\) Has serious nonhealing wound, ulcer, or bone fracture. 21) Has received a live vaccine within 30 days prior to the first dose of investigational product.\n\n22\\) Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of investigational product.\n\nNote: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks or 5 half-lives (whichever is longer) after the last dose of the previous investigational agent.\n\n23\\) Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of investigational product.\n\n24\\) Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy \\[e.g., ≤10 mg prednisone\\] for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted.\n\n25\\) Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\nNote: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n\n26\\) Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n\n27\\) Patients with co-existing active HBV and HCV infections. 28) Has an active infection including tuberculosis or human immunodeficiency virus (positive HIV antibodies).\n\n29\\) Participants with proteinuria \\>1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥1 g\u002F24 hours will be ineligible.\n\n30\\) Has had an allogenic tissue\u002Fsolid organ transplant. 31) Other conditions that, in the investigator's judgment, would increase study risk, interfere with results, or render the participant ineligible.",{"count":249,"type":22},40,[82],"This is a single-arm, open-label Phase IIa study designed to evaluate the efficacy, safety, and PK of CVM-1118 in combination with Sintilimab (Tyvyt ®) and TACE in participants with incurable\u002Fnon-metastatic HCC.\n\nApproximately 40 participants will be enrolled, all receiving CVM-1118 (200 mg orally \\[PO\\], twice daily \\[BID\\]) in combination with Sintilimab (200 mg via intravenous \\[IV\\] infusion every 3 weeks \\[Q3W\\]) and TACE. All participants will initiate treatment with CVM-1118 and Sintilimab on Cycle 1 Day 1 (C1D1), with each cycle lasting 21 days, continuing until the occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, for 2 years (i.e., Cycle 34) or study termination (whichever occurs first). CVM-1118 will be temporarily suspended from 2 days prior to each TACE procedure until 7 days post-TACE. The protocol permits conventional TACE (cTACE) or drug-eluting beads TACE (DEB-TACE) based on investigator's discretion, with the requirement that each participant maintains the same TACE modality throughout the treatment period. The first TACE procedure will be initiated between weeks 2-4 (C1D15 - C2D8) following systemic therapy initiation, with a maximum of 2 TACE treatments per lesion, an interval of ≥1 month between TACE sessions, and no more than 4 TACE treatments in total per participant.\n\nThe study comprises four periods: screening, treatment, safety follow-up, and survival follow-up. During the screening period, participants will undergo required examinations and evaluations. Eligible participants will enter the treatment period to receive the combination regimen. Tumor response will be assessed per RECIST v1.1 and mRECIST (see Appendix 1), with evaluations conducted every 9 weeks (±1 week) following initial dosing. During the safety follow-up period, all participants will undergo final safety assessments 28 days (+7 days) after investigational product cessation or prior to initiating new antitumor therapy. Subsequently, participants will enter the survival follow-up period with 12-week interval contacts to document disease status, anti-tumor therapies received, survival status, and other relevant clinical information until death, loss to follow-up, consent withdrawal, or study closure (whichever occurs first).\n\nThroughout the study, participants will undergo scheduled safety evaluations and PK blood sampling at designated timepoints. Subsequent PK sampling schedules may be adjusted or eliminated based on accumulated pharmacokinetic data from preceding participants.\n\n* CVM 1118 will be administered at 200 mg, PO, BID. Treatment continues until unacceptable toxicity, disease progression, death, consent withdrawal, for 2 years (i.e., Cycle 34), or study termination (whichever occurs first). CVM-1118 will be temporarily suspended from 2 days prior to each TACE procedure until 7 days post-TACE. CVM-1118 should be swallowed whole with a glass of water in a fasted state, with no food intake for at least 2 hours before and 1 hour after CVM 1118 administration. CVM 1118 should be administered at approximately the same time each day. Investigators are permitted to adjust the dosing for participants as required by referring to the \"Dose Adjustment\".\n* Sintilimab will be administered at 200 mg, IV, Q3W. Treatment continues until unacceptable toxicity, disease progression, death, consent withdrawal, for 2 years (i.e., Cycle 34) or study termination (whichever occurs first). Investigators are permitted to adjust the drug administration regimen for participants as required by referring to the \"Dose Adjustment\".\n* TACE modality for each participant, including the choice between cTACE and DEB-TACE, will be determined by investigators at their discretion; however, each participant must remain consistent with the selected TACE modality (cTACE or DEB-TACE) throughout the treatment period. The first TACE procedure will be initiated 2-4 weeks after the start of systemic therapy (C1D15 to C2D8), with a maximum of 2 treatments per lesion (minimum 1-month interval between TACE sessions) and up to 4 treatments per participant in total.",[28],[254,255,256,257,258,259],"Oncology","Hepatocellular Carcinoma (HCC)","Hepatoma","TACE","Sintilimab","CVM-1118","2026-04-17",{"date":262,"type":37},"2026-04-22",{"date":264,"type":22},"2026-03-31",{"date":266,"type":22},"2029-12-31",{"name":268,"class":269},"TaiRx, Inc.","INDUSTRY",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":23,"phases":277,"briefSummary":278,"conditions":279,"keywords":283,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":293,"leadSponsor":295,"locationsCount":4},"100634142","a-clinical-trial-of-firsekibart-tislelizumab-and-lenvatinib-in-patients-with-unresectable-tp53-mutated-hepatocellular-carcinoma-100634142","NCT07535840","A Clinical Trial of Firsekibart, Tislelizumab, and Lenvatinib in Patients With Unresectable, TP53-Mutated Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Ability to understand and sign written informed consent prior to any study-related procedures.\n\nAge ≥18 years at the time of signing informed consent.\n\nHistologically or cytologically confirmed advanced or unresectable hepatocellular carcinoma (HCC).\n\nDocumented disease progression after prior systemic immunotherapy, including at least one PD-(L)1 inhibitor.\n\nConfirmed TP53 mutation in fresh liver tumor tissue by central laboratory testing.\n\nDetermined by liver tumor MDT to be unsuitable for curative surgery (R0 resection not feasible, insufficient normal liver volume, or other criteria).\n\nBCLC stage B or C.\n\nAt least one measurable lesion per RECIST v1.1 confirmed by BICR.\n\nECOG performance status 0-1.\n\nChild-Pugh class A within 7 days prior to randomization.\n\nAdequate organ and bone marrow function within 7 days prior to enrollment:\n\nANC ≥1.5×10\\^9\u002FL, Platelets ≥75×10\\^9\u002FL, HGB ≥9 g\u002FdL\n\nTBIL ≤2×ULN, ALT\u002FAST ≤5×ULN, Albumin ≥28 g\u002FL, ALP ≤5×ULN\n\nCreatinine ≤1.5×ULN or CCr ≥50 mL\u002Fmin, urine protein \\\u003C2+ (or 24-h urine protein \\\u003C1 g if baseline ≥2+)\n\nINR ≤2.3 or PT prolongation ≤6 sec\n\nExpected survival ≥12 weeks.\n\nWomen of childbearing potential and male participants with partners of childbearing potential must use effective contraception during treatment and for 6 months after last dose.\n\nAbility and willingness to comply with study procedures and visits.\n\nExclusion Criteria:\n\n* Candidates suitable for local curative therapy.\n\nMixed liver tumors containing sarcomatoid or intrahepatic cholangiocarcinoma components.\n\nHematologic malignancies.\n\nHistory of hepatic encephalopathy or prior liver transplantation.\n\nSymptomatic pleural effusion, ascites, or pericardial effusion requiring drainage; asymptomatic small effusions allowed.\n\nActive HBV (HBV DNA \\>2000 IU\u002FmL) or HCV (HCV RNA \\>10\\^3 copies\u002FmL) infection; co-infection HBsAg+\u002FHCV Ab+ excluded.\n\nCNS metastases.\n\nSignificant recent variceal bleeding (within 6 months).\n\nLife-threatening hemorrhagic events within 3 months.\n\nSignificant thromboembolic events within 6 months.\n\nUse of high-dose aspirin (\\>325 mg\u002Fday) or other platelet inhibitors within 2 weeks prior to first dose.\n\nUnresolved grade ≥2 toxicities from prior therapies (excluding hair loss or asymptomatic lab abnormalities).\n\nSymptomatic heart failure NYHA II-IV or LVEF \\\u003C50%.\n\nUncontrolled arrhythmias or congenital long QT syndrome, QTc \\>500 ms.\n\nActive bleeding disorders or on thrombolytic therapy.\n\nRecent history of gastrointestinal perforation, fistula, obstruction, or significant bowel disease.\n\nRadiotherapy within 3-7 weeks prior to first dose with residual toxicity.\n\nHistory of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced lung injury, or severe impaired lung function.\n\nActive tuberculosis or treatment for TB within 1 year.\n\nHIV infection or active, untreated syphilis.\n\nActive or uncontrolled severe infection within 4 weeks prior to first dose.\n\nActive autoimmune disease requiring systemic treatment within 2 years. Known primary immunodeficiency.\n\nUse of systemic immunosuppressants within 4 weeks prior to first dose (nasal\u002Finhaled steroids at physiologic dose allowed).\n\nReceipt of live attenuated vaccines within 4 weeks prior to first dose.\n\nMajor surgery within 4 weeks prior to first dose, or unhealed wounds. Minor procedures like IV lines excluded.\n\nUncontrolled metabolic disorders or organ\u002Fsystemic disease posing excess risk.\n\nHistory of other malignancy within 5 years, except curatively treated basal cell carcinoma, squamous cell carcinoma, or in situ carcinoma.\n\nKnown hypersensitivity to study drugs or formulation components.\n\nHistory of aortic dissection or visceral artery aneurysm.\n\nParticipation in another clinical trial within 4 weeks prior to first dose.\n\nPregnant or breastfeeding women.\n\nExtensive metastatic disease (≥5 lesions) or major vascular invasion.\n\nOther acute or chronic diseases, psychiatric conditions, or lab abnormalities deemed by investigator to increase risk or interfere with study.",{"count":7,"type":22},[108],"This study aims to evaluate the effectiveness and safety of a combination therapy with Fuxinqibai monoclonal antibody, Tislelizumab, and Lenvatinib in patients with advanced, unresectable TP53-mutated hepatocellular carcinoma (HCC) who have previously failed systemic immunotherapy.\n\nEligible patients will receive:\n\nFuxinqibai 200 mg IV every 3 weeks Tislelizumab 200 mg IV every 3 weeks Lenvatinib 8 mg (≤60 kg) or 12 mg (\\>60 kg) orally once daily Treatment will continue until disease progression, unacceptable toxicity, start of a new anticancer therapy, withdrawal of consent, or other protocol-defined reasons. Tumor response will be evaluated by RECIST v1.1 every 6 weeks, and confirmed after 4 weeks if response is observed.\n\nSafety will be monitored through adverse events and laboratory tests, graded according to NCI CTCAE v5.0. After treatment ends, patients will be followed every 6 weeks for tumor assessment and every 12 weeks for survival, until death, loss to follow-up, or withdrawal of consent.\n\nPrimary Objective: To assess the objective response rate (ORR) of the combination therapy.\n\nSecondary Objectives: To evaluate overall efficacy, safety, and explore potential biomarkers predicting treatment response.",[28,280,281,282],"TP53 Gene Mutation","Unresectable","Resistant Cancer",[284,89,285,286,287,288,289],"Firsekibart","Lenvatinib","TP53-mutant hepatocellular carcinoma","Unresectable HCC","Advanced liver cancer","Single-arm study","2026-04-10",{"date":260,"type":37},{"date":188,"type":22},{"date":294,"type":22},"2027-06",{"name":296,"class":44},"Tongji Hospital",{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":23,"phases":306,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":313,"leadSponsor":315,"locationsCount":4},"100632824","phase-2-neoadjuvant-tislelizumab-lenvatinib-vs-surgery-alone-in-stage-ia-hcc-with-narrow-margin-100632824","NCT07518706","Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin","A Phase II Study Comparing Neoadjuvant Tislelizumab Plus Lenvatinib Followed by Surgery Versus Surgery Alone in Patients With Stage Ia Hepatocellular Carcinoma and an Anticipated Narrow Surgical Margin","Inclusion Criteria:\n\n1. The patient voluntarily participates in this study and provides written informed consent.\n2. Age ≥18 years at the time of consent; male or female.\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.\n4. Child-Pugh class A hepatic function.\n5. Histologically\u002Fcytologically confirmed, or clinically diagnosed according to accepted diagnostic criteria, primary hepatocellular carcinoma (HCC), with a single tumor measuring 2-5 cm in greatest diameter (CNLC stage IA).\n6. At enrollment, the lesion meets the criteria for surgically resectable disease per the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition); and an anticipated narrow surgical margin (resection margin \\\u003C1 cm) is expected due to tumor size and\u002For location, including any of the following:\n\n   * Lesion adjacent to the main trunk of the portal vein or first-order branches;\n   * Lesion adjacent to the inferior vena cava or the root of the hepatic veins;\n   * Lesion located in the caudate lobe.\n7. No prior local or systemic antitumor therapy for HCC.\n8. At least one measurable lesion per RECIST v1.1.\n9. Adequate function of major organs within 14 days prior to initiation of study treatment, as defined below:\n\n(1) Hematology (no blood transfusion within 14 days before screening; no granulocyte colony-stimulating factor \\[G-CSF\\] use; and no pharmacologic correction except for hemoglobin): absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; platelets ≥75×10\\^9\u002FL; hemoglobin ≥90 g\u002FL.\n\n(2) Serum chemistry (no albumin infusion within 14 days before screening): serum albumin ≥29 g\u002FL; total bilirubin ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤5×ULN; serum creatinine ≤1.5×ULN or creatinine clearance (CrCl) \\>50 mL\u002Fmin (Cockcroft-Gault formula below).\n\nMale: CrCl = (140 - age) × weight \u002F (72 × serum Cr) Female: CrCl = \\[(140 - age) × weight \u002F (72 × serum Cr)\\] × 0.85 Weight in kg; serum Cr in mg\u002FdL. (3) International normalized ratio (INR) ≤2.3, or prothrombin time (PT) prolongation ≤6 seconds above the institutional normal control.\n\n(4) Urine protein \\\u003C2+; if urine protein is ≥2+, a 24-hour urine protein quantification may be performed, and patients with 24-hour urine protein \\\u003C1.0 g are eligible.\n\n10\\. Viral hepatitis management:\n\n* For patients with active hepatitis B virus (HBV) infection: HBV DNA must be \\\u003C500 IU\u002FmL (if the site reports in copies\u002FmL only, \\\u003C2,500 copies\u002FmL), and the patient must have received anti-HBV therapy for at least 14 days before initiation of study treatment (per local standard of care, e.g., entecavir) and be willing to continue antiviral therapy throughout the study.\n* Patients who are hepatitis C virus (HCV) RNA positive must receive antiviral therapy per local standard treatment guidelines, and liver function abnormalities must be no greater than CTCAE Grade 1.\n\n  11\\. Contraception: Women of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during study treatment and for 6 months after the last dose; a negative serum or urine pregnancy test within 7 days prior to enrollment is required; women must not be breastfeeding. Male participants must agree to use effective contraception during the study and for 6 months after the end of the study.\n\n  12\\. The participant is able and willing to comply with the protocol requirements and follow-up schedule.\n\nExclusion Criteria:\n\n1. Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed-cell carcinoma, or fibrolamellar carcinoma; any other active malignancy concurrent with HCC or within the past 5 years, except for definitively treated localized tumors (e.g., basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ).\n2. Planned or prior solid-organ transplantation or allogeneic bone marrow transplantation (corneal transplantation is allowed).\n3. Known hypersensitivity to macromolecular protein products, or known allergy to any excipients of tislelizumab.\n4. Any active autoimmune disease or a history of autoimmune disease.\n5. Use of immunosuppressive agents, or systemic or absorbable topical corticosteroid therapy for immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent), that is ongoing within 2 weeks prior to enrollment.\n6. Clinically symptomatic ascites or pleural effusion requiring therapeutic paracentesis, thoracentesis, or drainage.\n7. Uncontrolled clinically significant cardiac symptoms or disease, including:\n\n(1) New York Heart Association (NYHA) class II or higher heart failure; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n\n8\\. Current (within the past 3 months) gastrointestinal conditions including esophageal varices, active gastric or duodenal ulcer, ulcerative colitis, portal hypertension, or active bleeding from unresected tumor(s), or any other condition judged by the investigator to pose a risk of gastrointestinal bleeding or perforation.\n\n9\\. History or current evidence of severe bleeding (blood loss \\>30 mL within the past 3 months), hemoptysis (\\>5 mL of fresh blood within the past 4 weeks), or a thromboembolic event within the past 12 months (including stroke and\u002For transient ischemic attack).\n\n10\\. Active infection, or fever of unknown origin \\>38.5°C during screening or prior to the first dose (fever judged by the investigator to be tumor-related is allowed).\n\n11\\. Congenital or acquired immunodeficiency, such as HIV infection. 12. Receipt of a live attenuated vaccine within 4 weeks prior to administration of study treatment.\n\n13\\. Use of traditional Chinese medicine with antitumor indications within 2 weeks prior to the first dose, or receipt of medications with immunomodulatory effects within 2 weeks prior to the first dose.\n\n14\\. Known history of abuse of psychoactive drugs, alcoholism, or illicit drug use.\n\n15\\. Ongoing treatment-related serious adverse events prior to enrollment in this study.\n\n16\\. Any condition that, in the investigator's opinion, makes the participant unsuitable for the study, including factors that may necessitate premature discontinuation (e.g., other serious diseases \\[including psychiatric disorders\\] requiring concomitant treatment, severe laboratory abnormalities, or family\u002Fsocial circumstances that may compromise participant safety or interfere with data and specimen collection).",{"count":305,"type":22},60,[82],"Postoperative recurrence remains a major limitation to long-term survival in hepatocellular carcinoma (HCC). In addition, a narrow surgical margin is widely regarded as a risk factor for recurrence. Neoadjuvant therapy may represent a strategy to reduce the risk of recurrence, thereby improving long-term outcomes. Tislelizumab plus lenvatinib has demonstrated promising efficacy with manageable safety in advanced HCC. Therefore, we will conduct a phase II study to compare neoadjuvant tislelizumab plus lenvatinib followed by surgery versus surgery alone in patients with stage IA HCC and an anticipated narrow surgical margin.",[28],"2026-04-01",{"date":311,"type":37},"2026-04-09",{"date":211,"type":22},{"date":314,"type":22},"2029-04-30",{"name":168,"class":44},{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":324,"briefSummary":325,"conditions":326,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":4},"100632575","phase-2-a-prospective-single-arm-exploratory-study-of-the-safety-and-efficacy-of-neoadjuvant-treatment-with-ql1706-an-anti-pd-1anti-ctla-4-bispecific-antibody-in-resectable-stage-ib-and-iia-hepatocellular-carcinoma-with-high-recurrence-risk-100632575","NCT07515469","A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD-1\u002FAnti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk","A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With Iparomlimab and Tuvonralimab Injection, an Anti-PD-1\u002FAnti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk","Inclusion Criteria:\n\n* Patients voluntarily participate in this study and sign the informed consent form.\n* Aged 18 to 75 years, male or female.\n* ECOG Performance Status (PS) score of 0 to 1.\n* Child-Pugh liver function classification: Grade A.\n* Histopathologically confirmed primary hepatocellular carcinoma (HCC), and the lesions meet the surgical resection indications specified in the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition).\n* Preoperatively, evaluated by the investigator, with high recurrence risk factors, meeting at least one of the following: Stage IB: Single tumor with maximum diameter \\> 5 cm; 2-3 tumors with maximum tumor diameter ≤ 3 cm；Stage IIA: 2-3 tumors with maximum tumor diameter \\> 3 cm.\n* According to the RECIST 1.1 criteria, the patient has at least one measurable lesion (measurable lesion with a long diameter ≥ 10 mm on CT\u002FMRI scan or lymph node lesion with a short diameter ≥ 15 mm on CT\u002FMRI scan, and the measurable lesion has not received local treatment such as radiotherapy or cryotherapy).\n* Expected survival time ≥ 6 months\n* possess normal and sound organ function\n* Females of childbearing age must agree to use contraceptive measures (such as intrauterine device, contraceptives or condoms) during the medication period and within 6 months after the end of medication; serum or urine pregnancy test is negative within 7 days before study enrollment, and must be a non-lactating patient; males must agree to use contraceptive measures during the study period and within 6 months after the end of the study.\n* The subject has good compliance and is willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Previous radiotherapy, chemotherapy, concurrent chemoradiotherapy or other targeted therapy.\n* Known hilar cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar carcinoma; other active malignant tumors except HCC within 5 years or concurrently.\n* Hypertension that cannot be well controlled with antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); previous hypertensive crisis or hypertensive encephalopathy.\n* The subject has a history of other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) or concurrent malignant tumors.\n* Previous treatment with Iparomlimab and Tuvonralimab or other PD-1\u002FPD-L1\u002FCTLA-4 inhibitors; known previous allergy of the subject to macromolecular protein preparations or any component of Iparomlimab and Tuvonralimab.\n* The subject has any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); subjects with vitiligo or asthma that was completely relieved in childhood and does not require any intervention in adulthood can be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included.\n* The subject is using immunosuppressants, or systemic or absorbable local hormone therapy for immunosuppressive purposes (dose \\> 10 mg\u002Fday prednisone or other hormones with equivalent efficacy), and continues to use them within 2 weeks before enrollment.\n* Clinically symptomatic ascites or pleural effusion requiring therapeutic paracentesis or drainage.\n* Uncontrolled clinical symptoms or diseases of the heart, such as: Heart failure of NYHA Class II or above；Unstable angina pectoris；Myocardial infarction within 1 year；Patients with clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.\n* The patient currently (within 3 months) has esophageal varices, active gastroduodenal ulcer, ulcerative colitis, portal hypertension and other digestive tract diseases, or active bleeding from unresected tumors, or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation.\n* Previous or current severe bleeding (bleeding \\> 30 ml within 3 months), hemoptysis (\\> 5 ml of fresh blood within 4 weeks) or thromboembolic events (including stroke events and\u002For transient ischemic attack) within 12 months.\n* The subject has an active infection or unexplained fever \\> 38.5 ℃ during screening or before the first dose (fever caused by tumor can be included as judged by the investigator).\n* Patients with objective evidence of previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.\n* The subject has congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria; for hepatitis B: HBV DNA ≥ 10⁴\u002Fml; for hepatitis C: HCV RNA ≥ 10³\u002Fml); chronic hepatitis B virus carriers with HBV DNA \\\u003C 2000 IU\u002Fml (\\\u003C 10⁴ copies\u002Fml) can be enrolled only if they receive antiviral treatment during the trial.\n* Live vaccine接种 within 4 weeks before study medication or likely to be vaccinated during the study period.\n* The subject has a known history of psychotropic drug abuse, alcoholism or drug addiction.\n* The investigator deems that the subject should be excluded from this study, for example, as judged by the investigator, the subject has other factors that may lead to the forced termination of the study in the middle, such as other serious diseases (including mental diseases) requiring combined treatment, severe laboratory test abnormalities, or family or social factors that may affect the safety of the subject or the collection of data and samples.",{"count":178,"type":22},[82],"This study aims to investigate the efficacy and safety of neoadjuvant therapy with Iparomlimab and Tuvonralimab Injection (anti-PD-1 and anti-CTLA-4 antibody combination) in patients with resectable hepatocellular carcinoma at high risk of recurrence (Stage IB, Stage IIA).",[28,327,328],"Iparomlimab and Tuvonralimab Injection","Neoadjuvant Immunotherapy",{"date":330,"type":37},"2026-04-07",{"date":332,"type":22},"2026-05-30",{"date":334,"type":22},"2030-10-30",{"name":168,"class":44},{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":4},"100631058","intelligence-system-for-predicting-atezolizumab-bevacizumab-response-and-clinical-outcomes-in-unresectable-hepatocellular-carcinoma-100631058","NCT07495735","Intelligence System for Predicting Atezolizumab-Bevacizumab Response and Clinical Outcomes in Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n* (i) Clinical or pathological diagnosis of HCC;\n* (ii) Administration of atezolizumab-bevacizumab treatment;\n* (iii) At least 18 years old.\n\nExclusion Criteria:\n\n* (i) Lack of key clinical data (laboratory test results), or lack of enhanced CT images taken within one month before treatment;\n* (ii) Comorbid with other malignant tumors;\n* (iii) PS score \\> 2 or Child-Pugh score \\> 7;\n* (iv) Unable to evaluate tumor response;\n* (v) Loss to follow-up.",{"count":343,"type":22},400,"This study is a multicenter retrospective clinical research, led by the First Affiliated Hospital of Wenzhou Medical University, and jointly conducted by other sub-centers. The aim is to develop an non-invasive artificial intelligence system for predicting the response and clinical outcomes of patients with unresectable hepatocellular carcinoma (uHCC) to the treatment with atezolizumab combined with bevacizumab (T+A). In response to the clinical situation where approximately half of uHCC patients do not respond to the standard T+A therapy and traditional invasive biopsy is unable to fully reflect the heterogeneity of the tumor microenvironment, this study plans to retrospectively collect the data of 400 patients who met the inclusion and exclusion criteria from January 2020 to November 2025. The study will systematically summarize multi-dimensional data such as enhanced CT images within one month before treatment, baseline characteristics, serum markers, liver disease factors, and tumor stage. By integrating these clinical features with deep learning imageomics features extracted from images, the research team is dedicated to constructing and validating a safe, non-invasive, and reproducible prediction model, with the aim of achieving precise identification of the benefit population before implementing immunotherapy combined with anti-angiogenic treatment, and providing a powerful intelligent tool support for optimizing clinical treatment decisions and improving patient survival prognosis.",[28,346],"Atezolizumab and Bevacizumab in Hepatocellular Carcinoma","2026-03-24",{"date":349,"type":37},"2026-03-27",{"date":351,"type":22},"2026-03-22",{"date":353,"type":22},"2026-12-30",{"name":355,"class":44},"First Affiliated Hospital of Wenzhou Medical University",{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":373,"leadSponsor":375,"locationsCount":4},"100629465","phase-3-a-study-of-neoadjuvant-tislelizumab-plus-lenvatinib-in-resectable-hcc-at-high-risk-of-recurrence-100629465","NCT07475026","A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence","Tislelizumab Plus Lenvatinib as Neoadjuvant Therapy for Patients With Resectable HCC at High Risk of Recurrence: a Prospective, Multicenter, Randomized Controlled Phase III Study","Inclusion Criteria:\n\n1. Voluntarily participates in this study and provides written informed consent.\n2. Aged 18 to 75 years, inclusive; male or female.\n3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.\n4. Child-Pugh class A liver function.\n5. China Liver Cancer (CNLC) stage Ib to IIa.\n6. Histologically\u002Fcytologically confirmed HCC, or clinically diagnosed primary hepatocellular carcinoma according to accepted diagnostic criteria, with lesions meeting the criteria for surgical resection as defined in the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 edition).\n7. At least one measurable lesion per RECIST v1.1.\n8. Estimated life expectancy ≥ 6 months.\n9. Adequate major organ function as defined below, without transfusion of any blood components or use of hematopoietic growth factors within 14 days prior to assessment:\n\n   * Hematology\n\n     * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³\n     * Platelet count ≥ 100,000\u002Fmm³\n     * Hemoglobin ≥ 5.6 mmol\u002FL (9 g\u002FdL)\n   * Hepatic and renal function\n\n     * Serum creatinine (SCr) ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula)\n     * Total bilirubin (TBIL) ≤ 1.5 × ULN\n     * AST and\u002For ALT ≤ 2.5 × ULN\n     * Urine protein \\\u003C 2+; if urine protein is ≥ 2+, 24-hour urine protein must be ≤ 1 g.\n10. Adequate coagulation function, with no active bleeding and no thrombotic disease:\n\n    * International normalized ratio (INR) ≤ 1.5 × ULN\n    * Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n    * Prothrombin time (PT) ≤ 1.5 × ULN\n11. Contraception requirements:\n\n    * Women of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during study treatment and for 6 months after the last dose; must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must not be breastfeeding.\n    * Men with partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the end of study treatment.\n12. Demonstrates good compliance and is able\u002Fwilling to complete required follow-up.\n\nExclusion Criteria:\n\n1. Prior antitumor therapy for the current HCC, including radiotherapy, chemotherapy, concurrent chemoradiotherapy, other locoregional therapies (e.g., TACE, HAIC), or prior immunotherapy or targeted therapy.\n\n   Note: Patients who developed recurrence after prior surgery may be enrolled; if prior postoperative adjuvant therapy was given, enrollment is allowed only if ≥6 months have elapsed since completion of adjuvant therapy.\n2. Known cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular-cholangiocarcinoma, or fibrolamellar carcinoma; or any other active malignancy besides HCC within the past 5 years or concurrently (except cured basal cell carcinoma of the skin and cervical carcinoma in situ).\n3. Hypertension inadequately controlled with antihypertensive therapy (systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg); or history of hypertensive crisis or hypertensive encephalopathy.\n4. Known hypersensitivity to macromolecular protein preparations, or known allergy to tislelizumab, lenvatinib, or any of their excipients.\n5. Any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis\u002Fcolitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). Patients with vitiligo, or asthma that completely resolved in childhood and requires no intervention in adulthood, may be eligible. Patients with asthma requiring medical intervention with bronchodilators are not eligible.\n6. Use of immunosuppressive agents or systemic, or absorbable topical, corticosteroids for immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to enrollment.\n7. Symptomatic ascites or pleural effusion requiring therapeutic paracentesis or drainage.\n8. Uncontrolled clinically significant cardiac symptoms or disease, including any of the following:\n\n   * New York Heart Association (NYHA) class \\> II heart failure\n   * Unstable angina\n   * Myocardial infarction within 1 year\n   * Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention\n9. Within the past 3 months, presence of gastrointestinal conditions such as esophageal varices, active gastric or duodenal ulcer, ulcerative colitis, portal hypertension, or active bleeding from an unresected tumor; or any other condition judged by the investigator to confer a risk of gastrointestinal bleeding or perforation.\n10. History of or current severe bleeding (within 3 months, bleeding volume \\>30 mL), hemoptysis (within 4 weeks, \\>5 mL fresh blood), or thromboembolic events within 12 months (including stroke and\u002For transient ischemic attack).\n11. Active infection, or unexplained fever \\>38.5°C during screening or prior to first dose (fever judged by the investigator to be tumor-related is allowed).\n12. Objective evidence of prior or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired pulmonary function.\n13. Congenital or acquired immunodeficiency, such as HIV infection.\n14. Receipt of a live vaccine within 4 weeks prior to study drug administration, or anticipated need for live vaccination during the study.\n15. Known history of psychotropic drug abuse, alcoholism, or illicit drug use.\n16. Anticipated inability or unwillingness to comply with required study procedures, assessments, and follow-up (including completion of standard-of-care evaluations not covered by the study), as judged by the investigator.\n17. Any other condition that, in the investigator's judgment, makes the subject unsuitable for the study, including factors that may lead to premature study discontinuation (e.g., other serious diseases \\[including psychiatric disorders\\] requiring concomitant treatment, severe laboratory abnormalities, or family\u002Fsocial factors that may compromise subject safety or the collection of data and specimens).",{"count":364,"type":22},198,[366],"PHASE3","This is a prospective, multicenter, randomized controlled, phase 3 study to explore the efficacy and safety of neoadjuvant tislelizumab plus lenvatinib in patients with resectable HCC at high risk of recurrence.",[28],"2026-03-11",{"date":371,"type":37},"2026-03-16",{"date":332,"type":22},{"date":374,"type":22},"2030-12-31",{"name":168,"class":44},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":70},"100584172","impact-of-radiotherapy-on-ctdna-in-patients-with-hepatocellular-carcinoma-100584172","NCT06885879","Impact of Radiotherapy on ctDNA in Patients With Hepatocellular Carcinoma","Impact of Radiotherapy on the Dynamic Changes of Circulating Cell-free DNA in Patients With Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Patients aged ≥ 18 years old\n* Eastern Cooperative Oncology Group (ECOG) performance 0 to 1\n* Confirmed diagnosis of Hepatocellular carcinoma (HCC)\n* Tumour size ≥ 3cm\n* Patients planning on undergoing Stereotactic Body Radiation Therapy (SBRT) for HCC\n* Prior radiofrequency ablation at a different site, or prior surgery are eligible\n* Child-Pugh A liver function\n* Life expectancy longer than 12 weeks\n* At least one measurable treatment lesion according to RECIST 1.1\n* Written informed consent must be obtained prior to any study related procedures\n* Adequate haematological function (Hemoglobin ≥ 8.5g\u002FdL; Platelet Count ≥ 75x109\u002FL; Antenatal Care ≥ 1.5x109\u002FL; international normalised ratio ≤ 1.5)\n* Adequate hepatic function (albumin ≥ 28g\u002Fl; Bilirubin ≤ 1.5xULN; Alanine transaminase \\\u003C 5 times upper limit normal)\n* Adequate renal function (serum creatinine ≤ 1.5 times the upper limit of normal range; Sodium ≥ 130mmol\u002FL; Potassium ≥ 3.0mmol\u002FL)\n* Able to read, understand and provide written consent\n\nExclusion Criteria:\n\n* Histology shows sarcomatoid HCC, fibrolamellar HCC, mixed cholangiocarcinoma-hepatocellular carcinoma\n* Presence of other malignancy than HCC within 5 years from diagnosis of HCC\n* Prior Transarterial chemoembolization (TACE) within 3 months\n* Previous radiotherapy to the abdomen\n* Previous yttrium-90 chemoembolization\n* Repetitive history of non-healing wounds or ulcers within 2 months of inclusion\n* Pregnant or lactating females at any time during the study\n* Active autoimmune disease requiring systemic therapy in the past 2 years\n* Diagnosis of immunodeficiency (including Human Immunodeficiency Viruses)\n* Patients with coagulopathy or on anticoagulant will be excluded from liver biopsy",{"count":384,"type":22},15,"Radiotherapy is increasingly being used in the management of hepatocellular carcinoma (HCC) as a standalone treatment, or in combination with systemic therapy. Stereotactic Body Radiation Therapy (SBRT) causes cell death directly (via double-stranded breaks) and indirectly (via vascular bed damage or promotion of antitumour immunity). Unfortunately, the effect of cell death is not immediate and takes time. As a result, the typical arterial phase hyperenhancement on imaging may persist up to 12 months after radiotherapy, and it is not necessarily suggestive of presence of viable tumours. Therefore, there is no consensus on ideal timing of response assessment following radiotherapy to HCC. Therefore, a blood-based biomarker which can be done frequently and monitored dynamically, could be preferred for response assessment after radiotherapy. Circulating tumour DNA (ctDNA) is an emerging and promising biomarker in cancer management, which has been shown useful in cancer screening, guiding treatment, and informing prognosis. Currently, most of the clinical applications of ctDNA revolve around either the presence of ctDNA, or the genomic changes associated with these molecules. Biological properties of ctDNA such as fragment length, jaggedness of fragments, or epigenetic changes may provide additional information related to the tumour characteristics and its sensitivity to anti-cancer treatments. These biological properties of ctDNA are relatively unexplored in the context of radiotherapy. It is unknown whether these properties can be utilized for monitoring treatment response. We therefore propose to study the biological properties of ctDNA in relation to HCC patients undergoing radiotherapy.",[28],"2026-03-02",{"date":389,"type":37},"2026-03-04",{"date":391,"type":37},"2025-04-08",{"date":393,"type":22},"2028-07-31",{"name":395,"class":44},"Chinese University of Hong Kong",{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":404,"targetDuration":406,"studyType":55,"phases":4,"briefSummary":407,"conditions":408,"keywords":411,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":420,"locationsCount":4},"100624521","surgery-vs-watch-and-wait-strategy-in-complete-responders-for-hepatocellular-carcinoma-switch-100624521","NCT07410715","Surgery vs. Watch-and-Wait Strategy in Complete Responders for Hepatocellular Carcinoma (SWITCH)","Surgery Versus Maintenance After Conversion-therapy-Achieved Complete\u002FPartial Response in Hepatocellular Carcinoma: a Prospective Multicenter Non-randomized Cohort Study","SWITCH","Inclusion Criteria:\n\n1. Aged 18-80 years.\n2. Diagnosed with locally advanced, metastatic, and\u002For initially unresectable hepatocellular carcinoma (uHCC) via histology\u002Fcytology or clinical criteria (AASLD standards for cirrhotic patients; histopathological confirmation required for non-cirrhotic patients).\n3. Previously judged unresectable or inappropriate for resection by MDT during initial diagnosis or disease course, with at least one evaluable lesion per RECIST v1.1.\n4. Completed conversion therapy \\[systemic therapy (PD-1\u002FPD-L1 ± TKI) ± local therapy (TACE\u002FHAIC\u002Fradiation\u002Fablation, etc.)\\], achieved CR or PR (primarily assessed by mRECIST, with concurrent RECIST v1.1 documentation), and confirmed via re-evaluation with the same imaging modality ≥4 weeks later.\n5. Meets necessary conditions for resection: Child-Pugh Class A liver function, ICG R15 \\\u003C30%, and future liver remnant (FLR) accounting for ≥40% of standard liver volume (SLV) in patients with chronic liver disease, hepatic parenchymal injury, or cirrhosis, or ≥30% in patients without liver fibrosis or cirrhosis.\n6. For patients with previous portal vein\u002Fhepatic vein\u002Finferior vena cava tumor thrombus (without atrial tumor thrombus), enrollment is permitted only if the thrombus has significantly regressed after conversion therapy, MDT confirms feasibility of R0 resection, and risks are acceptable.\n7. ECOG performance status 0-1.\n8. Adequate organ and bone marrow function, as evidenced by: hemoglobin ≥90g\u002FL; absolute neutrophil count ≥1.5×10⁹\u002FL; platelets ≥60×10⁹\u002FL; total bilirubin ≤1.5×upper limit of normal (ULN); AST, ALT, and ALP ≤2.5×ULN; serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥50ml\u002Fmin (Cockcroft-Gault formula); urine protein \\\u003C(++) or 24-hour urine protein \\\u003C1.0g.\n9. Normal coagulation function without active bleeding: INR ≤1.5×ULN; APTT ≤1.5×ULN.\n10. For patients with active hepatitis B virus (HBV) infection: those already receiving anti-HBV therapy (per local standard treatment) must agree to continue during the study; those not receiving anti-HBV therapy must initiate treatment (per local standard treatment) during screening and agree to continue throughout the study.\n11. For patients with HCV infection: excluded if HCV RNA is detectable.\n12. No pregnancy or pregnancy plans: fertile females must have a negative urine\u002Fserum pregnancy test within 7 days before first dosing and agree to use effective contraception during the study and for 120 days after last dosing; non-sterilized males must agree to use effective contraception during the study and for 120 days after last dosing.\n\nExclusion Criteria:\n\n1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma-HCC.\n2. Extrahepatic metastasis confirmed by chest, abdominal, and pelvic CT and\u002For MRI.\n3. Inability to achieve R0 resection.\n4. Previous liver transplantation or on the liver transplantation waiting list.\n5. Decompensated cirrhosis (persistent or refractory ascites, hepatic encephalopathy, progressive jaundice, etc.); Child-Pugh Class B with score ≥8 or Class C; ALBI Grade 3.\n6. Significant and uncontrollable portal hypertension (e.g., markedly elevated HVPG with recurrent variceal bleeding, refractory ascites).\n7. Active gastrointestinal bleeding within the past 4 weeks or uncorrectable coagulation disorders.\n8. Active infection\u002Fsepsis or unresolved Grade ≥2 immune-related adverse events (irAEs).\n9. Severe cardiopulmonary\u002Frenal insufficiency (e.g., NYHA Class III-IV, recent myocardial infarction\u002Fstroke, dialysis dependency).\n10. Pregnancy or lactation.\n11. Other active malignant tumors within the past 5 years (exceptions for low-risk tumors such as basal cell carcinoma of the skin or carcinoma in situ of the cervix).\n12. Inability to undergo standardized imaging assessments (multiphase contrast-enhanced CT\u002FMRI) or poor compliance.",{"count":405,"type":22},100,"3 Years","The \"Surgery versus Maintenance after Conversion-therapy-achieved Complete\u002FPartial Response in Hepatocellular Carcinoma (SWITCH)\" study is a multicenter, open-label, prospective non-randomized cohort study with the protocol number SWITCH-01 (Version 0.1, dated October 5, 2025). Sponsored by West China Hospital of Sichuan University and led by Principal Investigator Wu Hong, the study involves 10 participating centers and has completed NCT registration. Its core objective is to evaluate and compare the efficacy and safety of two management strategies-surgical resection and maintenance therapy-in patients with hepatocellular carcinoma (HCC) who have achieved complete response (CR) or partial response (PR) after conversion therapy and are deemed eligible for curative liver resection (R0) by a multidisciplinary team (MDT). The study is designed to address the clinical dilemma of optimal management for initially unresectable HCC patients who attain favorable responses to conversion therapy, providing high-level evidence for clinical decision-making.",[28,409,410],"Watch & Wait","Surgery",[112,412,413],"watch and wait","surgery","2026-02-12",{"date":416,"type":37},"2026-02-13",{"date":418,"type":22},"2026-03-01",{"date":266,"type":22},{"name":421,"class":44},"West China Hospital",{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":433,"conditions":434,"keywords":435,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":443,"leadSponsor":445,"locationsCount":4},"100624624","phase-2-lenvatinib-and-pembrolizumab-with-or-without-bcaa-in-unresectable-hcc-100624624","NCT07412054","Lenvatinib and Pembrolizumab With or Without BCAA in Unresectable HCC","A Multicenter, Open-Label, Randomized, Phase II Study of Lenvatinib Plus Pembrolizumab With or Without Branched-Chain Amino Acids in Unresectable Hepatocellular Carcinoma","BLP-HCC","Inclusion Criteria:\n\n1. Adults aged ≥18 years and \\\u003C75 years at the time of enrollment.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n3. Histologically or cytologically confirmed hepatocellular carcinoma (HCC), excluding fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular-cholangiocarcinoma; or clinically diagnosed HCC according to the American Association for the Study of Liver Diseases (AASLD) criteria.\n4. Unresectable Barcelona Clinic Liver Cancer (BCLC) stage B or C disease, as assessed by the investigator.\n5. At least one measurable lesion according to RECIST version 1.1.\n6. Adequate liver function defined as Child-Pugh class A (score 5-6).\n7. Adequate hematologic function: absolute neutrophil count ≥1.5 × 10⁹\u002FL, hemoglobin ≥9.0 g\u002FdL, and platelet count ≥100 × 10⁹\u002FL.\n8. Adequate hepatic and renal function: total bilirubin ≤1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 × ULN; serum creatinine ≤1.5 × ULN.\n9. Adequate coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN.\n10. Participants of childbearing potential must agree to use effective contraception during the study and for at least 120 days after the last dose of study treatment; female participants of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose of study treatment.\n11. Ability to understand and willingness to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women.\n2. Prior treatment with systemic targeted therapies (including sorafenib or lenvatinib), immune checkpoint inhibitors (including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies), or any form of cellular immunotherapy.\n3. Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapies (such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatment.\n4. Active or uncontrolled infection, including but not limited to uncontrolled acute exacerbation of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active tuberculosis, human immunodeficiency virus (HIV) infection with significantly reduced CD4 counts, or severe bacterial, fungal, or viral infections requiring intravenous antimicrobial therapy.\n5. History of another malignancy within 3 years prior to enrollment, except for adequately treated localized malignancies (such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or cervical carcinoma in situ).\n6. Severe psychological or psychiatric disorders.\n7. Significant cardiovascular disease or cardiac dysfunction, including but not limited to:\n\n   1. New York Heart Association (NYHA) class III-IV heart failure;\n   2. Myocardial infarction, severe angina, coronary stent placement, or coronary artery bypass grafting within 6 months prior to enrollment;\n   3. Clinically significant ventricular arrhythmias or persistent atrial fibrillation;\n   4. Uncontrolled hypertension (blood pressure ≥150\u002F90 mmHg despite optimal medical therapy).\n8. Severe pulmonary disease, including:\n\n   1. Severe chronic obstructive pulmonary disease (COPD) or interstitial lung disease requiring long-term oxygen therapy;\n   2. Active severe pulmonary infection.\n9. Severe renal impairment, including acute or chronic renal failure with estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m² or requiring dialysis.\n10. History or presence of significant bleeding tendency, including but not limited to:\n\n    1. Major gastrointestinal bleeding within 6 months prior to enrollment;\n    2. Untreated high-risk esophageal or gastric varices;\n    3. Severe coagulation abnormalities (e.g., INR \\>2.0, unless due to stable anticoagulation therapy).\n11. Concurrent participation in another clinical trial, unless it is an observational, non-interventional study or the follow-up phase of an interventional study.\n12. History of hepatic encephalopathy, refractory ascites, or severe portal hypertension syndrome caused by hepatic vein or portal vein thrombosis, deemed unsuitable for study treatment by the investigator.\n13. Known history of severe hypersensitivity reactions to lenvatinib, pembrolizumab, branched-chain amino acid preparations, or any of their excipients.\n14. Expected survival of less than 3 months.\n15. Participation in another interventional clinical trial within 4 weeks prior to enrollment (during the treatment phase), or currently receiving treatment in another interventional study; participants who have entered the follow-up phase of another clinical trial and do not interfere with the assessment of this study may be enrolled.\n16. Any other condition that, in the investigator's judgment, may compromise participant safety or interfere with the evaluation of study efficacy.",{"count":431,"type":22},234,[82],"The goal of this clinical trial is to learn whether adding branched-chain amino acids (BCAAs) to lenvatinib and pembrolizumab improves treatment outcomes in adults with unresectable hepatocellular carcinoma (HCC). The study will also evaluate the safety of this combination treatment.\n\nThe main questions this study aims to answer are:\n\nDoes the addition of BCAAs improve the time patients live without their cancer getting worse? Does the combination treatment improve tumor response compared with standard treatment alone? What medical problems or side effects do participants experience during treatment? Researchers will compare lenvatinib plus pembrolizumab with BCAAs to lenvatinib plus pembrolizumab alone to see whether adding BCAAs provides additional benefit for patients with unresectable HCC.\n\nParticipants will:\n\nBe randomly assigned to receive lenvatinib and pembrolizumab with or without oral BCAAs Take lenvatinib by mouth every day and receive pembrolizumab by intravenous infusion every 3 weeks Continue treatment until disease progression, unacceptable side effects, or withdrawal from the study Visit the clinic regularly for physical examinations, imaging tests, blood tests, and safety assessments",[28],[30,436,285,437,438],"Branched-chain amino acids","Pembrolizumab","Randomized controlled trial","2026-02-09",{"date":441,"type":37},"2026-02-17",{"date":418,"type":22},{"date":444,"type":22},"2028-06-01",{"name":446,"class":44},"Fudan University",{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":459,"conditions":460,"keywords":464,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":70},"100621906","phase-1-a-phase-1-study-of-tgi-5-as-monotherapy-and-in-combination-with-nivolumab-in-subjects-with-locally-advancedmetastatic-solid-tumors-100621906","NCT07376707","A Phase 1 Study of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced\u002FMetastatic Solid Tumors","A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics\u002FPharmacodynamics, and Antitumor Activity of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced\u002FMetastatic Solid Tumors","TGI5","Inclusion Criteria:\n\n* 1\\. Male or female subject age ≥18 years at the time of informed consent. 2. Phase 1a and dose escalation part of Phase 1b: Subjects with histologically or cytologically diagnosed unresectable locally advanced\u002Fmetastatic solid tumors, mainly but not limited to CRC, HCC, melanoma, NSCLC.\n\nDose expansion part of Phase 1b:\n\n* Cohort 1: Subjects with histologically or cytologically diagnosed unresectable locally advanced and\u002For metastatic CRC.\n* Cohort 2: Subjects with histologically or cytologically diagnosed unresectable locally advanced and\u002For metastatic melanoma.\n* Cohort 3: Subjects with histologically or cytologically diagnosed unresectable locally advanced and\u002For metastatic NSCLC.\n* Cohort 4: Subjects with other histologically or cytologically diagnosed unresectable locally advanced\u002Fmetastatic solid tumors.\n\n  3\\. Subjects should have documented progression of disease despite all standard therapy or are intolerant of all standard therapy, or for whom no effective standard therapy exists. (Standard therapies are defined as treatments recommended by local guidelines, including but not limited to, chemotherapy, radiation, target therapies based on mutation status, immunotherapy, and surgery in general).\n\nDose expansion part of Phase 1b:\n\n* Cohort 1: Subjects with unresectable locally advanced and\u002For metastatic CRC o At least 2 prior standard chemotherapy\u002Ftherapy regimens are required with documented progression or intolerability to the treatment.\n\n  * Standard chemotherapy regimens include all the following ones (if eligible and no contraindication): Fluoropyrimidine-containing regimen, and\u002For oxaliplatin-containing regimen, and\u002For irinotecan-containing regimen (treatment with a FOLFIRINOX regimen will count as 2 regimens).\n  * With or without an anti-VEGF therapy (e.g., bevacizumab).\n  * At least one of the anti-EGFR monoclonal antibodies (cetuximab or panitumumab) for KRAS wild-type subjects if clinically indicated.\n  * For subjects with a known microsatellite instability high (MSI-H):\n\n    1. Prior treatment with an at least 2 doses of approved or investigational immune checkpoint inhibitor is required with documented progression or intolerability to the treatment.\n    2. Demonstrated disease progression after immune checkpoint inhibitor treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Appendix 5). The initial evidence of disease progression is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression, in the absence of rapid clinical progression. Once disease progression is confirmed, the initial date of disease progression documentation will be considered the date of disease progression.\n    3. Progressive disease that has been documented within 12 weeks from the last dose of immune checkpoint inhibitor.\n\n       Note: a line of therapy is generally considered \\>2 cycles of exposure to the same regimen followed by radiographically documented progression. Agents that are mechanistically similar (e.g., 5-fluorouracil and capecitabine) and are used interchangeably due to tolerability but not progression may be considered as components of the same regimen upon discussion with the medical monitor.\n  * Subjects must have progressed while receiving or after of the last administration of their last line of standard therapy or be unable to tolerate any of these standard treatments.\n  * Subjects who progressed on\u002Fwithin 3 months of adjuvant therapy with anti-PD-1 antibody will be allowed; subjects who received adjuvant chemotherapy and had recurrence\u002Fprogression with development of unresectable or metastatic disease during or within 6 months of completion of the adjuvant chemotherapy can count this as a line of therapy.\n* Cohort 2: Subjects with anti-PD-(L)1 antibody PD-1 relapsed\u002Frefractory melanoma\n\n  * PD-1 refractory disease as defined as progression on treatment with anti-PD-1 antibody administered either as monotherapy or in combination with other checkpoint inhibitors (anti-CTLA4 antibody or anti-LAG-3 antibody) or other therapies. Anti-PD-1 treatment progression is defined by meeting all of the following criteria:\n\n    1\\) Has received at least 2 doses of an approved or investigational anti-PD-1 antibody with documented progression or intolerability to the treatment.\n\n    2\\) Demonstrated disease progression after anti-PD-1 treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Appendix 5). The initial evidence of disease progression is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression, in the absence of rapid clinical progression. Once disease progression is confirmed, the initial date of disease progression documentation will be considered the date of disease progression.\n\n    3\\) Progressive disease that has been documented within 12 weeks from the last dose of anti-PD-1 antibody.\n  * Subjects who progressed on\u002Fwithin 3 months of adjuvant therapy with anti-PD-1 antibody will be allowed; an adjuvant therapy will count as 1 prior line of therapy if received within the prior 6 months.\n  * For patients with BRAF V600 mutations, treatment with BRAF and MEK inhibitors prior to initiation on trial is required, unless patients are intolerant of BRAF targeted therapy.\n  * Treatment must have been discontinued for disease progression or intolerance to therapy.\n* Cohort 3: Subjects with anti-PD-(L)1 antibody relapsed\u002Frefractory NSCLC\n\n  o Anti-PD-(L)1 antibody refractory disease as defined as progression on treatment with anti-PD-(L)1 inhibitor administered either as monotherapy or in combination with platinum-based chemotherapy or other therapies. Anti PD (L)1 treatment progression is defined by meeting all of the following criteria:\n  1. Has received at least 2 doses of an approved or investigational anti-PD-(L)1 inhibitor with documented progression or intolerability to the treatment.\n  2. Has demonstrated disease progression after anti-PD-(L)1 inhibitor as defined by RECIST v1.1 (Appendix 5). The initial evidence of disease progression is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression, in the absence of rapid clinical progression. Once disease progression is confirmed, the initial date of disease progression documentation will be considered the date of disease progression.\n  3. Progressive disease has been documented within 12 weeks from the last dose of anti-PD-(L)1 inhibitor.\n\n     o Subjects who progressed on\u002Fwithin 3 months of adjuvant therapy with anti PD (L)1 inhibitor will be allowed; an adjuvant therapy will count as 1 prior line of therapy if received within the prior 6 months.\n\n     o Documented disease progression during or after platinum-based chemotherapy alone or intolerability to the treatment for subjects with contraindications to anti PD (L)1 inhibitors.\n     * Patients with NSCLC with known oncogenic driver (including but not limited to EGFR, ALK, ROS, MET alterations) must have received and progressed past driver-specific therapy.\n     * Treatment must have been discontinued for disease progression or intolerance to therapy.\n* Cohort 4: Subjects with other histologically or cytologically diagnosed unresectable locally advanced\u002Fmetastatic solid tumors All subject in Phase 1b must meet PD-L1 expression ≥1%. 4. Subjects must have at least one evaluable lesion in Phase 1a or at least one measurable lesion in Phase 1b as defined by RECIST v1.1 (Appendix 5) which has not received radiotherapy (or progressive disease after radiotherapy).\n\n  5\\. ECOG PS (Appendix 6) of 0\\~2. 6. Life expectancy ≥3 months. 7. Subjects have sufficient baseline organ function and laboratory data meet the following criteria at enrollment:\n* Hematological (without need for hematopoietic growth factor or transfusion support within 2 weeks prior to enrollment):\n\n  1\\) ANC ≥1.5×109\u002FL. 2) Hemoglobin (HGB) ≥90 g\u002FL. 3) Platelet (PLT) ≥75×109\u002FL.\n* Hepatic:\n\n  1\\) AST and ALT ≤2.5×ULN (≤5×ULN for subjects with liver metastases). 2) Total bilirubin (TBil) ≤1.5×ULN, or TBil ≤3.0×ULN for subjects with liver cancer or liver metastases. Subjects with Gilbert's syndrome may enroll if direct bilirubin ≤1.5×ULN.\n* Renal:\n\n  1\\) Creatinine apparent clearance (CL) \\>50 mL\u002Fmin according to modification Cockcroft-Gault equation (140-age \\[year\\])×body weight \\[kg\\]×1.23×(0.85 if female)\u002Fserum creatinine \\[μmol\u002FL\\]).\n* Coagulation:\n\n  1\\) International normalized ratio (INR) ≤1.5. 2) Activated partial thromboplastin time (APTT) ≤1.5×ULN. 8. Woman of child-bearing potential must have a negative serum pregnancy test within 7 days prior to treatment. A female subject of nonchildbearing potential will have had at least 12 continuous months of natural (spontaneous) amenorrhea, follicle stimulating hormone level ≥40 mIU\u002FmL at screening, and an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms), or have had surgical bilateral oophorectomy, hysterectomy, or tubal ligation ≥6 weeks prior to screening.\n\n  9\\. Female subjects of childbearing potential or male subjects with a partner of childbearing potential must agree to use effective contraception at the time of informed consent and continuing through the study until 6 months after the last dose of study treatment (Appendix 4).\n\nExclusion Criteria:\n\n* 1\\. Subject with known active central nervous system (CNS) primary tumor or metastases.\n\nNote: Subject with previously treated CNS primary tumor\u002Fmetastases can participate provided they are clinically stable for at least 2 weeks, have no evidence of new or enlarging brain metastases, and there has been no increase in steroid dose for 14 days prior to the first dose of TGI-5 to manage CNS symptoms. Subjects with carcinomatous meningitis or leptomeningeal spread, or spinal cord compression are excluded regardless of clinical stability.\n\n2\\. History of intercurrent severe chronic or active infections:\n\n1. Subjects with active hepatitis B, defined as: if hepatitis B virus surface antigen (HbsAg) positive, hepatitis B virus (HBV) deoxyribonucleic acid (DNA) assay should be performed, and HBV DNA is above the limit quantification.\n2. Subjects with active hepatitis C, defined as: if hepatitis C virus (HCV) antibody positive, HCV ribonucleic acid (RNA) assay should be performed, and HCV RNA is positive.\n3. Known history of acquired immune deficient syndrome (AIDS) or human immunodeficiency virus (HIV) infection.\n4. Subjects with HIV infection may be eligible if CD4+ T cell counts ≥350 cells\u002FµL and without a history of AIDS-defining opportunistic infections.\n5. Other severe chronic within 4 weeks prior to the first dose of TGI-5, including but not limited to hospitalization for complications of infection, bacteremia, severe pneumonia, or active tuberculosis. Or uncontrolled active infections or unexplained fever \\>38°C within 7 days prior to first dose of TGI-5.\n\n3\\. Has a history of active autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study drug.\n\nWith the following exceptions: clinically stable autoimmune thyroid disease; treatment with inhaled or topical corticosteroids such as ocular, intra-articular, and intranasal ≤10 mg daily of prednisone equivalent; short-term use of corticosteroids (no more than 7 days) for prophylaxis (e.g., to prevent contrast medium allergy or non-autoimmune allergic diseases); and replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes, physiologic corticosteroid replacement for adrenal or pituitary insufficiency).\n\n4\\. Has a history of symptomatic interstitial lung disease. 5. Toxicities of prior therapies have not been resolved to Grade ≤1 or baseline as per NCI-CTCAE v5.0, except for alopecia, skin hyperpigmentation, Grade 2 neuropathy and Grade 2 endocrinopathy that is well controlled by replacement therapy.\n\n6\\. Subjects with severe or uncontrolled cardiovascular disorder requiring treatment, including any of the following:\n\n1. New York Heart Association (NYHA) class III or IV congestive heart failure.\n2. Left ventricular ejection fraction (LVEF) \\\u003C50% assessed by multiple-gated acquisition (MUGA) scan or echocardiogram (ECHO).\n3. Mean ECG QT interval corrected by Fridericia's formula (QTcF) \\>480 milliseconds (ms) obtained from triplicate 12-lead ECGs, or congenital long QT syndrome.\n4. Any of the following within 6 months prior to screening: Grade \\>2 ventricular arrhythmia, myocardial infarction, severe\u002Funstable angina (even if controlled with medication), coronary artery bypass graft, congestive heart failure, cerebrovascular accident, or transient ischemic attack.\n5. Presence of uncontrolled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg). Subjects with a history of hypertension are allowed if blood pressure is controlled to within these limits by anti-hypertensive treatment.\n6. Symptomatic pulmonary embolism within 6 months prior to initiation of study treatment.\n\n7\\. Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation.\n\n8\\. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years (Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and localized prostate cancer who have undergone potentially curative therapy. These subjects are not excluded).\n\n9\\. Evidence of clinically significant immunosuppression such as the following:\n\n1. Primary immunodeficiency state such as severe combined immunodeficiency disease (SCID).\n2. Concurrent opportunistic infection. 10. Presence of uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (monthly or more frequently).\n\n11\\. Previously treated with the following antitumor therapy (prior to the first dose of TGI-5):\n\n1\\) Previous treated with TIGIT-targeting therapy. 2) Chemotherapy, target therapy, immunotherapy, or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment, except:\n\n1. Washout period for nitrosoureas or mitomycin is ≤6 weeks.\n2. ≤5 half-lives or 2 weeks (whichever is longer) for fluoropyrimidines or small-molecule targeted agents.\n3. Washout period for herbal therapy with anticancer indications is ≤2 weeks.\n4. Anti-PD-1\u002FPD-L1 antibody therapy within 6 weeks. 3) Prior radiotherapy ≤4 weeks prior to the first dose of study treatment, with the exception of a single fraction of radiotherapy for the purposes of palliation, which is permitted.\n\n   4\\) Subject participated in any other clinical study and has received an investigational product within 28 days prior to the first dose of TGI-5.\n\n   12\\. Has received systematic immunomodulatory drugs within 14 days before the first dose of study drug, such as thymosin, IL-2, and IFN.\n\n   13\\. Has received a live vaccine within 4 weeks prior to the first dose of study drug.\n\n   14\\. Has a recent major surgery within 4 weeks prior to the first dose of study drug or is expected to undergo major surgery during the study.\n\n   15\\. Subject requiring anticoagulant treatment which cannot be safely interrupted, if medically needed for a study procedure (e.g., biopsy) based on the opinion of the investigator.\n\n   16\\. Subjects who have experienced Grade ≥3 irAEs from prior immunotherapies or who discontinue immunotherapy due to immune-related toxicities.\n\n   Note: Subjects with stable hypothyroidism on hormone replacement therapy are eligible.\n\n   17\\. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.\n\n   18\\. Pregnancy or lactation. Women who are willing to discontinue breastfeeding prior to administration of study drug and do not intend to resume breastfeeding may be enrolled.\n\n   19\\. Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product.\n\n   20\\. Pre-existing other serious medical conditions (e.g., active or chronic inflammatory lung disease have not resolved, uncontrolled acute or chronic nephropathy, uncontrolled pancreatitis, uncontrolled hepatopathy, uncontrolled diabetes mellitus, active gastric ulcer, gastrointestinal hemorrhage, uncontrolled epileptic seizure, and signs and symptoms of severe coagulopathy), familial or endemic disease that, in the opinion of the investigator, will interfere with planned staging, treatment, and follow-up, subject compliance, or will place the subject at high risk for treatment-related complications.\n\n   21\\. Subjects who are unwilling or unable to comply with study procedures and study restrictions, or in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n\n   22\\. Subjects who have contraindication for use of PD-1\u002FPD-L1 antibody (only for Phase 1b).",{"count":456,"type":22},194,[458],"PHASE1","This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK\u002FPD, and preliminary antitumor activity of TGI-5 as monotherapy and in combination with Nivolumab in subjects with unresectable locally advanced\u002Fmetastatic solid tumors.\n\nThe study consists of two parts: TGI-5 monotherapy (Phase 1a: including a dose escalation part and a dose expansion part), TGI-5 in combination with a fixed dose of Nivolumab (Phase 1b: including a dose escalation part and a dose expansion part).",[461,462,28,463],"CRC (Colorectal Cancer)","Melanoma (Skin Cancer)","NSCLC (Non-small Cell Lung Cancer)",[465,466],"TGI-5","Locally Advanced\u002FMetastatic Solid Tumors","2026-01-21",{"date":469,"type":37},"2026-01-29",{"date":471,"type":37},"2025-06-12",{"date":473,"type":22},"2027-12-31",{"name":475,"class":44},"Hefei TG ImmunoPharma Co., Ltd.",{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":483,"enrollmentInfo":484,"targetDuration":4,"studyType":23,"phases":486,"briefSummary":487,"conditions":488,"keywords":491,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":70},"100569086","needle-based-percutaneous-ablation-of-liver-tumors-100569086","NCT06689670","Needle-based Percutaneous Ablation of Liver Tumors.","To Evaluate the Safety and Performance of INT001 in the Percutaneous Ablation of Liver Tumors: A Prospective, Single-arm, Single-center Clinical Study","Inclusion Criteria:\n\n1. Diagnosis of primary or secondary liver cancer.\n2. ECOG Performance Status score of 0 - 2\n3. Age ≥18 years, \\\u003C100 years\n4. Life expectancy of ≥3 months\n5. Patient is unsuitable for surgical resection or transplantation\n6. Ability of the patient to understand and sign the Informed Consent Form describing the study's nature\n7. Volunteer's willingness and ability to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits\n\nExclusion Criteria:\n\n1. Decompensated liver function, specifically Child-Pugh C, moderate to severe ascites, coagulopathy, or severe cirrhosis.\n2. Signs of liver dysfunction: AST or ALT \\>5 times the upper limit of normal (ULN), Serum bilirubin level \\>2.0 mg\u002FdL\n3. Individuals with bleeding disorders.\n4. History of allergy or intolerance to contrast agents to be used during imaging for assessing treatment efficacy after INT001 application.\n5. Patients with life-threatening serious extrahepatic disease.\n6. Patients with concurrent conditions that, in the investigator's opinion, would prevent clinical benefit from the study procedure or could compromise patient safety or study objectives (including but not limited to ongoing infection, renal dysfunction, or morbidity).\n7. Significant medical or psychiatric illness.\n8. Pregnant or breastfeeding women or women planning to conceive within the next 6 months.\n9. Patients participating in another study investigating a device, drug, or procedure that may impact the study treatment outcome.\n10. Lesions that do not show contrast uptake on contrast-enhanced CT or MR angiography.\n11. Lesions that are not hypervascular on angiography.\n12. Patients who do not have CT or MR imaging available at the screening visit or are unwilling or unable to undergo MRI for various reasons during the study.","100 Years",{"count":485,"type":22},31,[108],"The goal of this clinical trial is to learn if INT001 can ablate liver tumors in adults in an outpatient setting. It will also help us learn about the safety of INT001. The main questions it aims to answer are:\n\n1. Using a needle under image guidance, the liver tumor is accessed and INT001 is injected. Upon injection into tumor, does INT001 ablate\u002Fkill the tumor entirely?\n2. What medical problems do participants experience when receiving INT001?\n\nParticipants will:\n\nReceive INT001 on day 1. Visit the clinic day 7, 30 and 90. Receive lab tests during each visit and MRI on day 30 and 90.",[489,28,490],"Liver Tumors","Metastatic Liver Tumor",[492,493,494,495,496],"liver","tumor","ablation","needle","out-patient","2026-01-15",{"date":65,"type":37},{"date":500,"type":37},"2024-10-28",{"date":502,"type":22},"2027-12",{"name":504,"class":269},"inTumo Therapeutics, Inc.",{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":4},"100620891","phase-2-efficacy-and-safety-of-radiotherapy-combined-with-tislelizumab-and-anlotinib-in-the-treatment-of-hepatocellular-carcinoma-complicated-with-portal-vein-tumor-thrombus-100620891","NCT07363512","Efficacy and Safety of Radiotherapy Combined With Tislelizumab and Anlotinib in the Treatment of Hepatocellular Carcinoma Complicated With Portal Vein Tumor Thrombus","Inclusion Criteria:\n\n1. Men aged between 18 and 75 or non-pregnant women;\n2. Sign the informed consent form;\n3. The researchers believe that the patients have the ability to comply with the research protocol;\n4. Hepatocellular carcinoma (HCC) is diagnosed histologically, cytologically or clinically. Patients with liver cirrhosis are clinically diagnosed according to the AASLD standard, while non-liver cirrhosis patients need to be confirmed by histology.\n5. Imaging examinations confirmed the presence of portal vein tumor thrombus;\n6. The disease is not suitable for radical surgery;\n7. Has not received any anti-tumor treatment in the past;\n8. At least one measurable (measurable according to RECIST1.1) untreated lesion;\n9. Tumor tissue samples before treatment (if available). If tumor tissue is available, submit one formalin-fixed, paraffin-embedded (FFPE) tumor sample in a paraffin block (preferred), or approximately 10-15 slides containing unstained, freshly cut, series sections, along with a relevant pathological report within 4 weeks of enrollment. If the FFPE samples described above are not available, any type of sample (including fine needle aspiration biopsy samples and cell mass samples) can also be accepted. A relevant pathological report should be provided along with the sample.\n10. The ECOG performance status score is 0 or 1;\n11. Child-Pugh grade A;\n12. Adequate hematology and organ function, based on the following laboratory test results obtained within 7 days before enrollment (unless otherwise specified) : absolute neutrophil count (ANC)≥1.5×109\u002FL (1500\u002FμL), no granulocyte colony-stimulating factor support; Lymphocyte count ≥0.5×109\u002FL (500\u002FμL); Platelet count ≥50×109\u002FL (50,000 \u002FμL), no blood transfusion; Hemoglobin ≥90 g\u002FL (9g\u002FdL);\n13. Before enrollment, any acute and clinically significant treatment-related toxicity (caused by previous treatment) must have been alleviated to ≤ grade 1, except for alopecia.\n14. The result of the HIV antibody test during screening was negative;\n15. Patients with active hepatitis B virus (HBV) infection: HBV DNA obtained within 28 days before randomization \\\u003C 2000IU\u002FmL, and having received at least 14 days of anti-HBV treatment (treated according to local standard treatment, such as entecavir) before randomization and willing to continue treatment during the study period.\n\nExclusion Criteria:\n\n1. Current or previous history of autoimmune diseases or immune deficiencies\n2. History of meningitis;\n3. Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia can be seen on chest computed tomography (CT) images during the screening period. Radiation pneumonia has been allowed in the radiation area (fibrosis).\n4. Known active tuberculosis;\n5. Having major cardiovascular diseases (such as New York Heart Society Class II or more severe heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmia or unstable angina pectoris within 3 months prior to enrollment;\n6. History of congenital long QT syndrome or corrected QT interval at screening \\>500ms (calculated using the Fridericia method);\n7. A history of uncorrectable electrolyte disorders such as serum potassium, calcium or magnesium;\n8. Received major surgical treatment (excluding diagnosis) within 4 weeks before enrollment or is expected to require major surgical treatment during the study period;\n9. Malignant tumors other than HCC that have occurred within 5 years prior to enrollment, excluding those with negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as well-treated cervical cancer in situ, non-melanoma skin cancer, localized prostate cancer, carcinoma in situ or stage I uterine cancer;\n10. There was a severe infection within 4 weeks before enrollment, including but not limited to hospitalization due to infection, bacteremia or severe pneumonia complications;\n11. Previous allogeneic stem cell or solid organ transplantation;\n12. The patient cannot be followed up or is currently participating in other clinical trials;\n13. Subjects who the researchers considered unsuitable for inclusion in this study.",{"count":512,"type":22},27,[82],"For HCC patients with PVTT who the researchers believe can benefit from radiotherapy combined with tislelizumab and anlotinib, informed consent forms will be signed, and then they will receive the study treatment and be followed up. The research design is as follows:\n\nFirst, radiotherapy was administered. Three days ±1 day after the start of radiotherapy, tislelizumab and anlotinib treatment were initiated. Each cycle was three weeks, and the treatment continued until no toxicity was acceptable or clinical benefits were lost (evaluated by the researcher based on imaging, biochemical indicators, and the patient's clinical status).",[28],"2026-01-14",{"date":518,"type":37},"2026-01-23",{"date":520,"type":22},"2026-01-05",{"date":522,"type":22},"2028-11",{"name":119,"class":120},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":531,"targetDuration":4,"studyType":23,"phases":532,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":70},"100616789","phase-2-phase-iib-study-of-ast-3424-in-patients-with-akr1c3-high-expressing-advanced-hepatocellular-carcinoma-100616789","NCT07310173","Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma","Phase IIb, Randomized, Active-Controlled, Parallel-Group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AST-3424 in Patients With AKR1C3-High Expressing Advanced Hepatocellular Carcinoma Who Progressed After Systemic Therapy With Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n1. Patients with pathologically confirmed advanced hepatocellular carcinoma (HCC).\n2. Documented disease progression confirmed by medical imaging after failure of prior systemic therapy regimens containing immune checkpoint inhibitors (ICIs).\n3. Barcelona Clinic Liver Cancer (BCLC) stage B or C; ineligible for or refusing surgical resection or locoregional liver therapies (including transarterial intervention and ablation).\n4. Child-Pugh class A or B liver function (score ≤ 7), with no history of hepatic encephalopathy.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n6. At least one measurable extracranial lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. Expected survival ≥ 3 months.\n8. Availability of pathological tissue blocks or sections (including archived samples) for AKR1C3 expression and related biomarker analysis. Immunohistochemistry (IHC) results must confirm high expression of AKR1C3.\n9. Adequate organ function.\n10. For subjects positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb):\n\n    HBV DNA level must be \\\u003C 2000 IU\u002FmL or 10⁴ copies\u002FmL Subjects must be receiving anti-HBV therapy . This therapy must be maintained throughout the study period and for 6 months after the last dose of study drug.\n\n    For subjects positive for HCV antibody, HCV-RNA level must be below the lower limit of detection (LLOD) of the study center.\n11. Female subjects of childbearing potential must be non-lactating and have a negative pregnancy test result within 7 days prior to treatment initiation. A positive urine pregnancy test result must be confirmed by a serum pregnancy test.\n12. Female and male subjects of childbearing potential must agree to use effective contraceptive measures from the time of study enrollment until 6 months after the last dose of study drug.\n13. Subjects must voluntarily participate in the study, provide written informed consent after a full understanding of the study details, and have good compliance to cooperate with study treatment, observation, and follow-up procedures.\n\nExclusion Criteria:\n\n1. Patients with intrahepatic cholangiocarcinoma, dual-phenotype hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, or carcinosarcoma.\n2. Untreated active central nervous system (CNS) metastases. Subjects with CNS metastases who have received adequate treatment, achieved stable disease for at least 4 weeks confirmed by clinical examination and brain MRI during screening, require no steroid or anticonvulsant therapy, and present no clinical symptoms may be enrolled in the study.\n3. A history of other malignant tumors within 2 years, except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the lung, breast, or other sites, or other tumors whose related treatments will not interfere with the safety or efficacy evaluation of the study drug.\n4. A history of severe cardiovascular and cerebrovascular diseases.\n5. Has received anti-tumor therapies including locoregional radiotherapy, chemotherapy, immunotherapy, or targeted therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose; for treatment with nitrosourea or mitomycin C, a 6-week washout period is required; for oral fluoropyrimidine drugs or small-molecule targeted therapy drugs, only a 2-week washout period is needed.\n6. Has received major surgery other than diagnostic procedures or locoregional therapy targeting liver lesions within 4 weeks prior to the first dose.\n7. Has received investigational drugs in other clinical trials within 4 weeks prior to the first dose.\n8. All toxicities from prior anti-cancer therapies must have resolved to ≤ grade 1 at the start of study drug administration.\n9. Moderate to large symptomatic pleural effusion, pericardial effusion, or ascites requiring thoracentesis\u002Fparacentesis or with a history of thoracentesis\u002Fparacentesis within 2 weeks prior to the start of study treatment. .\n10. Need for concomitant use of strong CYP3A4 inhibitors or inducers during the study period.\n11. Any severe acute or chronic infections requiring systemic antibiotic or antiviral therapy at screening.\n12. Known human immunodeficiency virus (HIV) infection or positive syphilis test result.\n13. Pregnant, lactating, or women planning to become pregnant.\n14. Concomitant diseases that may interfere with the conduct of the study, or physical abnormalities that the investigator deems pose an excessive risk to the subject, including but not limited to a history of significant gastrointestinal bleeding within 3 months prior to enrollment or a high risk of bleeding, active peptic ulcer, uncontrolled mental illness, or mental disorders that may interfere with the subject's understanding of the informed consent form or cooperation with treatment.\n15. A history of hypersensitivity to ethanol or propylene glycol.\n16. Other reasons judged by the investigator that make the subject unsuitable for participation in this clinical study.",{"count":201,"type":22},[82],"The goal of this clinical trial is to learn if drug AST-3424 works to treat AKR1C3 high expressing advanced hepatocellular carcinoma after failure of systemic therapy with immune checkpoint inhibitors. The main question it aims to answer is:\n\nDoes AST-3424 prolong survival in patients with AKR1C3-high Expressing advanced Hepatocellular Carcinoma who have progressed after immune checkpoint inhibitors based therapies?\n\nResearchers will compare AST-3424 to regorafenib (current optional therapy for target patients) to see if AST-3424 works.\n\nParticipants will:\n\nReceive AST-3424 infusion on Day 1 and Day 8 of each 21-day treatment cycle or take regorafenib once a day on Day 1 -Day 21 of each 28-day treatment cycle.",[28],"2025-12-29",{"date":537,"type":37},"2025-12-30",{"date":539,"type":22},"2026-01-01",{"date":541,"type":22},"2027-12-01",{"name":543,"class":269},"Zhejiang Hisun Pharmaceutical Co. Ltd.",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":552,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":4},"100616505","the-efficacy-of-preoperative-oral-administration-of-lactobacillus-reuteri-combined-with-preoperative-neoadjuvantconversion-immunotherapy-in-patients-with-primary-resectable-liver-cancer-100616505","NCT07306481","The Efficacy of Preoperative Oral Administration of Lactobacillus Reuteri Combined With Preoperative Neoadjuvant\u002FConversion Immunotherapy in Patients With Primary Resectable Liver Cancer","The Efficacy of Preoperative Oral Administration of Lactobacillus Reuteri Combined With Preoperative Neoadjuvant\u002FConversion Immunotherapy in Patients With Primary Resectable Liver Cancer: a Prospective Study","Inclusion Criteria:\n\n1. Understanding and voluntarily signing the informed consent form for this study;\n2. Age≥18 years and ≤75 years; gender not restricted;\n3. Histologically (pathologically), cytologically, or radiologically confirmed hepatocellular carcinoma (HCC);\n4. Patients who require preoperative immune checkpoint inhibitor (ICI) combination therapy followed by potentially curative hepatectomy;\n5. No prior systemic therapy for HCC, including chemotherapy, targeted therapy, or immunotherapy had been administered before enrollment.;\n6. Patients with a history of prior curative surgery or curative ablation are allowed, except for those with recurrence within 2 years post-curative treatment or prior receipt of other local therapies;\n7. At least one measurable lesion meets RECIST v1.1 criteria;\n8. Child-Pugh liver function rating: grade A or B;\n9. The expected survival period is greater than 3 months;\n10. Patients must be able to take food orally independently;\n11. Preoperative ECOG physical condition score 0-1 points;\n12. Normal coagulation function, no activebleeding or thrombotic diseases; A. International standardized ratio INR≤1.5×ULN; B. Partial thromboplastin time APTT≤1.5×ULN;\n13. Has adequate organ and bone marrow function, laboratory test values within 7 days prior to enrollment meet the following requirements (no blood components, cell growth factors, albumin, or other corrective drugs are allowed within 14 days prior to laboratory test), as follows: 1) Blood routine: absolute neutrophil count≥1.5×109\u002FL; platelet count≥75×109\u002FL; hemoglobin conten≥9.0 g\u002FdL. 2) Liver function: serum total bilirubin≤2× upper limit of normal value (ULN); alanine aminotransferase and aspartate transferas≤5×ULN; Serum albumin ≥28 g\u002FL; alkaline phosphatase≤5×ULN. 3) Renal function: serum creatinine≤1.5×ULN or clearance of creatinine≥50mL\u002Fmin(Cockcroft-Gault formula); Urine routine results showed that urine protein \\\u003C2+; For patients with urine protein ≥2+ on routine urine tests at baseline, 24-hour urine collection and 24-hour protein quantification \\\u003C1g should be performed.\n\nExclusion Criteria:\n\n1. Inability to comply with the study protocols or procedures;\n2. Known intrahepatic cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma (ICC more than 30%) and fibrolaminar cell carcinoma\n3. Hepatic encephalopathy, hepatorenal syndrome, or severe decompensated cirrhosis;\n4. Planned use of probiotics, yogurt, or bacterial-fortified foods during the treatment period;\n5. Use of probiotics or antibiotic within 2 months before the trial;\n6. Patients with severe mental illness;\n7. Patients under fasting or fluid restriction (e.g., complete bowel obstruction, active gastrointestinal bleeding, etc.);\n8. Patients with chronic digestive system diseases, such as irritable bowel syndrome, malabsorption syndrome, inflammatory bowel disease, or ileostomy;\n9. Allergy to the trial product or its components, inability to swallow tablets, unwillingness or inability to receive intravenous administration, or a history of severe infusion-related reactions to monoclonal antibodies or any other active malignancies during the initial study treatment administration;\n10. Participants in other drug, dietary supplement, probiotic, or prebiotic clinical studies within the past 1 months prior to enrollment\n11. Pregnant or lactating women;\n12. History of other malignancies within the past 5 years, except for completely resected basal cell carcinoma or squamous cell carcinoma of the skin, or cervical carcinoma in situ;\n13. Any medical or non-medical condition that the researcher deems unsuitable for participation.",{"count":249,"type":22},[108],"On the basis of previous studies, this study intends to explore the efficacy of preoperative oral administration of Lactobacillus reuteri (Lr) combined with preoperative neoadjuvant\u002Fconversion therapy in patients with primary resectable hepatocellular carcinoma (HCC). We hypothesize that this combination represents a novel, microbiota-based therapeutic strategy to facilitate perioperative hepatic recovery and improve long-term survival outcomes.\n\nThis study is an open-label, randomized, blank-controlled clinical trial. Patients undergoing liver resection were randomly allocated to one of two groups. The intervention group received preoperative oral Lactobacillus reuteri (Lr) supplementation alongside neoadjuvant\u002Fconversion immunotherapy. The control group received preoperative neoadjuvant\u002Fconversion immunotherapy alone. Fecal and peripheral blood samples will be collected at baseline (pre-medication), 3 days prior to surgery, and at 5 days, 1, 3, 6, 9, 12, 18, and 24 months postoperatively. Intraoperative liver tissue samples will also be obtained. Statistical analyses will be performed to compare intergroup differences in postoperative liver function recovery, overall survival, hepatic and peripheral immune markers, and gut microbiota composition.\n\nThis study aims to develop adjuvant strategies to enhance therapeutic outcomes for HCC patients undergoing preoperative neoadjuvant\u002Fconversion immunotherapy.",[28],"2025-12-14",{"date":535,"type":37},{"date":558,"type":22},"2025-12-20",{"date":560,"type":22},"2028-12-20",{"name":562,"class":120},"Fujian Cancer Hospital",{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":569,"targetDuration":4,"studyType":23,"phases":570,"briefSummary":571,"conditions":572,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":580,"locationsCount":70},"100616424","downstaging-unresectable-hepatocellular-carcinoma-to-resectable-disease-with-combined-immunotherapy-and-stereotactic-beamed-radiotherapy-a-pilot-study-100616424","NCT07305428","Downstaging Unresectable Hepatocellular Carcinoma to Resectable Disease With Combined Immunotherapy and Stereotactic Beamed Radiotherapy: a Pilot Study","Inclusion Criteria:\n\n* Diagnosis of HCC is made according to American Association for the Study of Liver Diseases (AASLD) practice guideline 2010: patients with cirrhosis of any etiology and patients with chronic hepatitis B (HBV) who may not have fully developed cirrhosis, the presence of liver nodule \\>1cm and demonstrated in a single contrast enhanced dynamic imaging \\[either computed tomography (CT) or magnetic resonance imaging (MRI)\\] of intense arterial uptake and \"washout\" in portal venous and delayed phases.\n* Tumor size 5-25 cm or number of lesions ≤3 or segmental portal vein involvement\n* Age: 18-80 years old\n* Child Pugh liver function class A-B7\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n\nExclusion Criteria:\n\n* Prior invasive malignancy\n* Prior radiotherapy to the region of liver or selective internal radiotherapy\n* Severe, active co-morbidity\n* Presence of extra-hepatic metastases (M1)\n* Main portal vein or inferior vena cava (IVC) thrombosis or involvement\n* Presence of ascites or encephalopathy\n* Contraindicated of SBRT:\n\n  * Any one hepatocellular carcinoma \\> 15 cm\n  * Total maximal sum of hepatocellular carcinoma \\> 25 cm\n  * More than 3 discrete hepatic nodule\n  * Direct tumor extension into the stomach, duodenum, small bowel, large bowel, common or main branch of biliary tree",{"count":178,"type":22},[108],"Hepatocellular carcinoma (HCC) is one of the commonest cancers worldwide and ranks the third on the incidence of cancer-related death. There are more than 500000 new cases diagnosed annually worldwide. The incidence and prevalence of HCC are on rising trend with the majority of the disease burden is in Asia where viral hepatitis B is endemic. Surgical resection, radiofrequency ablation (RFA) and liver transplantation (LT) represent the only chance of cure for HCC patients. Despite more aggressive surgical approach has been adopted in most Asian countries, yet curative intervention remains only amendable in 30% of patients. Most patients are diagnosed with intermediate or advanced stage diseases; the long-term cure rate is only 0-10%. Hence, every effort has been made in an attempt to convert inoperable HCC into operable disease (i.e. downstaging) in order to improve the chance of survival of these patients. The current study, to our knowledge, will be the first study in the field to deploy a novel treatment strategy to deploy both immunotherapy and stereotactic beamed radiotherapy to induce tumor shrinkage rendering it become operable cancer.",[28,573],"Unresectable Hepatocellular Carcinoma","2025-12-12",{"date":576,"type":37},"2025-12-26",{"date":578,"type":37},"2019-04-25",{"date":374,"type":22},{"name":581,"class":44},"The University of Hong Kong",{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":590,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":591,"targetDuration":4,"studyType":23,"phases":593,"briefSummary":594,"conditions":595,"keywords":596,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":70},"100614919","phase-2-the-efficacy-of-sequential-treatment-with-bevacizumab-combined-with-atezolizumab-in-advanced-liver-cancer-with-masld-100614919","NCT07285850","The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD","The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD Background: a Dual Arm, Multicenter, Randomized Controlled Study","ABATE-MASLD","Eligibility Criteria Inclusion Criteria\n\n* Age ≥ 18 years old (gender not limited)\n* ECOG performance status of 0-1\n* Preoperative imaging diagnosis of advanced hepatocellular carcinoma (BCLC stage C or D, unsuitable for surgery)\n* Ultrasound or MRI indicating moderate to severe fatty liver (Fibroscan CAP \\> 268 dB\u002Fm or MR fat score \\> 10%)\n* Willing to use contraceptive measures during the trial period\n* Expected survival time ≥ 3 months\n* At least one measurable lesion (per RECIST 1.1) that has not been irradiated\n* Organ function levels (within 7 days before first study medication) must meet the following:\n* Hematopoietic function: ANC ≥ 1.5×10⁹\u002FL, PLT ≥ 100×10⁹\u002FL, Hb ≥ 90 g\u002FL, no transfusion within 14 days\n* Liver function: TBIL ≤ 1.5×ULN, AST\u002FALT\u002FALP ≤ 2.5×ULN, serum creatinine ≤ 1.5×ULN, CrCl ≥ 50 mL\u002Fmin, ALB ≥ 30 g\u002FL, Child-Pugh A\n* Coagulation function: INR and APTT ≤ 1.5×ULN or within therapeutic range if on anticoagulants\n* Renal function: urinary protein ≤ 1+ (or ≤1 g\u002F24h if \\>1+)\n* Cardiac function: ECG normal or clinically insignificant, LVEF \\> 50%\n* Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dosing\n* Men and women of reproductive potential must use effective contraception during and for 12 months after treatment\n* Participants must voluntarily provide informed consent and have good compliance\n\nExclusion Criteria\n\n* Excessive alcohol consumption (weekly ethanol intake: males \\\u003C 210 g, females \\\u003C 140 g)\n* Tumor lesions previously treated with targeted therapy, immunotherapy, TACE, or radiotherapy\n* Pregnant or breastfeeding women, or positive pregnancy test at baseline\n* Central nervous system metastases diagnosed by CT, MRI, or PET-CT\n* Participation in another clinical drug or therapy trial within 4 weeks before first study dose\n* Major surgery within 4 weeks prior to first study dose, or incomplete recovery from surgery\n* Radiotherapy within 2 weeks before first study dose\n* History or presence of primary immunodeficiency or active autoimmune disease\n* History of organ transplantation or hematopoietic stem cell transplantation\n* Current use of immunosuppressants or corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) within 2 weeks\n* Positive for HIV antibody or Treponema pallidum antibody, or active hepatitis B\u002FC infection\n* Allergy to recombinant humanized PD-1 monoclonal antibody, VEGF monoclonal antibody, or components\n* Symptomatic pleural effusion, pericardial effusion, or ascites requiring clinical intervention\n* Severe cardiovascular disease within 12 months (e.g., CAD, CHF ≥ II, arrhythmias, MI)\n* Events within 6 months before first dose (e.g., DVT, PE, MI, PCI, ACS, CABG, stroke, TIA, embolism)\n* History of GI surgery, obstruction, bleeding, dysfunction, or malabsorption affecting drug absorption\n* Severe uncontrolled infection or comorbidity, or moderate\u002Fsevere renal impairment\n* Active pulmonary disease (interstitial pneumonia, COPD, asthma, tuberculosis history)\n* Abnormal coagulation (INR \\> 2.0, PT \\> 16 s), bleeding tendency, or thrombolytic\u002Fanticoagulant therapy (except prophylaxis)\n* Significant bleeding within 3 months (e.g., hemoptysis ≥ 2.5 mL, GI bleeding, varices, ulcers, vasculitis)\n* Known hereditary\u002Facquired bleeding or thrombotic disorders (e.g., hemophilia, thrombocytopenia)\n* History of substance abuse or mental disorders affecting compliance\n* Use of warfarin or coumarin derivatives within 14 days before or during treatment\n* Other severe acute\u002Fchronic conditions increasing risk or confounding results\n* Poor compliance or other conditions deemed unsuitable for trial participation",true,{"count":592,"type":22},20,[82,366],"This research plan involves a treatment approach for advanced hepatocellular carcinoma (HCC) in the context of metabolic-associated steatotic liver disease (MASLD). The study aims to compare the efficacy differences between sequential therapy and concurrent therapy using bevacizumab and atezolizumab for advanced HCC in MASLD. The research will focus on evaluating objective response rates, progression-free survival, disease control rates, and overall survival, while utilizing biomarker analysis to elucidate treatment mechanisms. Additionally, the study will examine treatment safety, including the incidence and severity of adverse events.",[28],[597,112,598],"MASH","immunotherapy","2025-12-10",{"date":601,"type":37},"2025-12-16",{"date":603,"type":37},"2025-10-20",{"date":605,"type":22},"2026-08-30",{"name":607,"class":44},"Eastern Hepatobiliary Surgery Hospital"]