[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"portal-vein-tumor-thrombus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:portal-vein-tumor-thrombus":103},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,74],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100630106",false,"NCT07483359","Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus","Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib and Tislelizumab for Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus: A Prospective, Multicenter, Single-arm Study","CONV3RSION","Inclusion Criteria:\n\nParticipants must meet all of the following inclusion criteria to be enrolled in this trial:\n\n1. Voluntarily sign the written informed consent form.\n2. Age 18 to 80 years (inclusive), male or female.\n3. Histologically or cytologically confirmed Hepatocellular Carcinoma (HCC) according to the \"Clinical Practice Guideline for Primary Liver Cancer (2024 Edition),\" and evaluated by a Multi-Disciplinary Team (MDT) as initially unresectable.\n4. No prior systemic anti-tumor therapy (including targeted therapy, immunotherapy, and systemic chemotherapy).\n5. Barcelona Clinic Liver Cancer (BCLC) stage C and China Liver Cancer (CNLC) stage IIIa, complicated with imaging-confirmed Vp3 portal vein tumor thrombus (PVTT, defined as tumor thrombus invading the first-order branches of the portal vein but not the main trunk).\n6. At least one measurable target lesion according to RECIST v1.1 criteria.\n7. Expected survival time of ≥ 3 months.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.\n9. Child-Pugh liver function class A or B (score ≤ 7).\n10. Adequate major organ function, meeting the following baseline laboratory criteria:\n\n    * Hematology: Hemoglobin ≥ 90 g\u002FL; Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\\^9\u002FL; Platelet count ≥ 75 x 10\\^9\u002FL.\n    * Biochemistry: Albumin ≥ 28 g\u002FL; Total Bilirubin ≤ 3 x Upper Limit of Normal (ULN); AST and ALT ≤ 5 x ULN; Alkaline Phosphatase (ALP) ≤ 5 x ULN; Serum Creatinine ≤ 1.5 x ULN.\n    * Coagulation: INR or Prothrombin Time (PT) ≤ 1.5 x ULN; Activated Partial Thromboplastin Time (APTT) ≤ 1.5 x ULN.\n11. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment, must not be breastfeeding, and must agree to use highly effective contraception during the study treatment and for at least 6 months after the last dose.\n12. Good compliance and willingness to cooperate with all study-related follow-up procedures.\n13. Assessed by the MDT as \"Potentially Resectable\" according to the \"Chinese expert consensus on conversion and perioperative therapy of primary liver cancer (2024 edition)\". This is defined as participants who are temporarily unsuitable for upfront surgical resection due to oncological factors (e.g., Vp3 PVTT indicating a high risk of early post-operative recurrence) or technical factors (e.g., massive tumor size leading to insufficient future liver remnant \\[FLR\\]), but who are expected to convert to an R0 resection and achieve significant clinical benefit following downstaging with the combination of FOLFOX-HAIC and systemic therapy.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded from the study:\n\n1. History of other active malignancies within 5 years (except for adequately treated basal cell carcinoma of the skin or papillary thyroid cancer).\n2. Evidence of extrahepatic metastasis confirmed by chest, abdomen, and pelvis CT and\u002For MRI scans.\n3. Presence of clinically significant ascites.\n4. History of hepatic encephalopathy.\n5. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on chest CT scan at screening.\n6. Severe infection within 4 weeks prior to enrollment, including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia.\n7. History of hypertensive crisis; or major cardiovascular disease within 3 months prior to starting study treatment (e.g., New York Heart Association \\[NYHA\\] Class II or worse heart failure, myocardial infarction, cerebrovascular accident, unstable arrhythmia, or unstable angina).\n8. Inadequately controlled arterial hypertension, defined as systolic blood pressure (BP) ≥ 150 mmHg and\u002For diastolic BP \\> 100 mmHg (based on an average of ≥ 3 BP readings obtained from ≥ 2 measurements). Achieving these parameters through the use of antihypertensive therapy is permitted.\n9. Severe vascular disease within 6 months (e.g., aortic aneurysm requiring surgical repair or peripheral arterial thrombosis); or a current or recent history of active autoimmune disease or immunodeficiency (including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis).\n10. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of the investigational drugs, may affect the interpretation of the results, or may place the patient at high risk for treatment-related complications.\n11. Use of systemic immunosuppressive medications within 2 weeks prior to the first dose of study treatment, or the expected need for long-term systemic immunosuppressive therapy during the study. Exceptions permitting the use of corticosteroids include: (1) prophylactic use to prevent allergic reactions to imaging contrast media (e.g., short-term dexamethasone); (2) topical, ophthalmic, intra-articular, otic, or inhaled corticosteroids with minimal systemic absorption; (3) physiological replacement doses of systemic corticosteroids (defined as ≤ 10 mg\u002Fday of prednisone or an equivalent corticosteroid).\n12. Evidence of bleeding diathesis or severe coagulopathy.\n13. Patients preparing to undergo, or who have previously received, a solid organ or allogeneic bone marrow transplant.","ALL","18 Years","80 Years",{"count":20,"type":21},38,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Patients with hepatocellular carcinoma (HCC) complicated by Vp3 portal vein tumor thrombus (PVTT) face a poor prognosis and are typically ineligible for surgical resection. This prospective study evaluates a conversion therapy regimen-utilizing a combination of FOLFOX-HAIC, Lenvatinib, and Tislelizumab-designed to induce significant regression of both the tumor burden and the PVTT. The primary objective is to determine the Technical Resectability Rate (TRR), assessing the potential for this triple-combination therapy to downstage initially unresectable disease to a state suitable for curative-intent R0 surgical resection.",[27,28],"Hepatocellular Carcinoma (HCC)","Portal Vein Tumor Thrombus",[30,31,32,33,34],"Conversion Therapy","Hepatic Arterial Infusion Chemotherapy","Tislelizumab","Lenvatinib","Vp3 Portal Vein Tumor Thrombus","RECRUITING","2026-05-25",{"date":38,"type":39},"2026-05-28","ACTUAL",{"date":41,"type":39},"2026-05-20",{"date":43,"type":21},"2028-05",{"name":45,"class":46},"First Hospital of China Medical University","OTHER",1,{"id":49,"slug":4,"hasResults":10,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100597712","NCT07062055","BITS-TO-HCC Study: HAIC+Iparomlimab\u002FTuvonralimab + Bevacizumab + SBRT for BCLC-C HCC With PVTT and\u002For Oligometastases","Bevacizumab Plus Iparomlimab\u002FTuvonralimab With Hepatic Artery Infusion Chemotherapy Followed by Stereotactic Body Radiotherapy in Patients With BCLC Stage C Hepatocellular Carcinoma With Thrombus and\u002For Extrahepatic Oligometastases (BITS-TO-HCC): Study Protocol of a Prospective, Single- Center, Single-Arm, Phase II Study","Inclusion Criteria:\n\n1. Male or female patients aged between 18 and 70 years.\n2. Unresectable HCC, BCLC Stage C according to the BCLC strategy-2025 update, with staging established via biopsy pathology and\u002For clinical diagnosis.\n3. Child-Pugh class A without clinically significant hepatic decompensation; Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n4. Metastatic burden and SBRT eligibility\n\n   * Extrahepatic oligometastatic disease defined as ≤3 involved organs with ≤5 total metastatic lesions\n   * All intended intrahepatic and\u002For extrahepatic SBRT targets must satisfy protocol-specified target-coverage, liver reserve, and organ-at-risk (OAR) constraints within a composite 5-fraction plan\n5. Prognosis \\& measurable disease\n\n   * Life expectancy ≥3 months\n   * ≥1 measurable lesion (per RECIST 1.1):\n   * Tumor: ≥10 mm (CT long axis)\n   * Lymph node: ≥15 mm (CT short axis)\n6. Prior therapy\n\n   * Prior locoregional therapy permitted：radiofrequency ablation (RFA), TACE, or HAIC, provided that:\n   * Documented radiographic progression or intolerance after the prior therapy\n   * Washout ≥28 days\n   * Treatment-related toxicities recovered to ≤Grade 1 (alopecia and peripheral neuropathy ≤Grade 2 allowed)\n7. Laboratory and virologic requirements\n\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤5 × upper limit of normal (ULN); total bilirubin ≤3 × ULN; serum albumin ≥28 g\u002FL\n   * Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL\u002Fmin\n   * Urine dipstick protein \\\u003C2+; if baseline dipstick proteinuria is ≥2+, 24-hour urinary protein must be \\\u003C1 g\n   * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN\n\nExclusion Criteria:\n\n1. Histopathological exclusions\n\n   * Mixed HCC subtypes: Fibrolamellar HCC or sarcomatoid HCC or cholangiocarcinoma components\n2. Curative local therapy candidacy\n\n   * Current candidacy for resection, liver transplant, or RFA\n3. RT infeasibility\n\n   * Prior radioembolization\n   * Single liver tumor ≥15 cm or total intrahepatic tumor diameter ≥20 cm\n   * more than 5 discrete intrahepatic parenchymal foci are present\n   * direct tumor extension into the stomach, duodenum, small bowel, or large bowel\n   * measurable common or main-branch biliary duct involvement\n   * Prior liver radiotherapy that would result in excessive overlap with the planned treatment fields\n4. Prior systemic therapies\n\n   * Received targeted-immunotherapy for HCC (e.g., PD-(L)1 inhibitors + tyrosine kinase inhibitors (TKIs))\n   * Prior immunotherapy: anti-PD-(L)1\u002FCTLA-4 or chimeric antigen receptor T-cell therapy\n5. Hemorrhage\u002Fportal hypertension and hepatic decompensation risk\n\n   * Variceal bleeding within 6 months.\n   * Untreated or high-risk esophagogastric varices (e.g., grade ≥2 on endoscopy within 3 months) or other clinical evidence of portal hypertension with high bleeding risk per investigator.\n   * Moderate or severe ascites\n   * History of or active hepatic encephalopathy\n   * History of hemoptysis (≥2.5 mL of bright red blood per episode) within 28 days before study treatment\n   * Evidence of bleeding diathesis or significant coagulopathy\n   * Current or recent (within 10 days before study treatment) use of aspirin (≥325 mg\u002Fday), dipyridamole, ticlopidine, clopidogrel, cilostazol, or therapeutic-dose oral\u002Fparenteral anticoagulants or thrombolytic agents\n6. Allergy to any component of iparomlimab\u002Ftuvonralimab or bevacizumab\n7. Comorbidities\n\n   * Active autoimmune disease or a history of autoimmune or inflammatory disease that may relapse; exceptions include hypothyroidism controlled with hormone replacement only, controlled celiac disease, and skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia)\n   * Any condition requiring systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medication within 14 days before study treatment\n   * Active or uncontrolled infection, including tuberculosis, or known HIV infection\n   * Prior allogeneic stem cell transplantation or organ transplantation\n   * Inadequately controlled hypertension, defined as systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure \\>90 mmHg despite optimal medical management, or a history of hypertensive crisis or hypertensive encephalopathy\n   * History within 6 months before study treatment of myocardial infarction, unstable angina, symptomatic heart failure (New York Heart Association class ≥II), cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other serious thromboembolic events\n   * Major surgical procedure within 28 days before study treatment, or serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture\n   * History within 6 months before study treatment of gastrointestinal perforation, abdominal or tracheoesophageal fistula, or intra-abdominal abscess","70 Years",{"count":56,"type":21},54,[24],"This single-center, prospective, single-arm Phase II clinical trial is designed to evaluate the efficacy and safety of combining hepatic artery infusion chemotherapy (HAIC, for up to 4 cycles) with iparomlimab\u002Ftuvonralimab plus bevacizumab followed by stereotactic body radiotherapy (SBRT) in patients with Barcelona Clinic Liver Cancer (BCLC) stage C hepatocellular carcinoma (HCC) who present with portal vein tumor thrombus (PVTT) or extrahepatic oligometastatic disease. The study aims to determine whether this combination strategy can prolong progression-free survival (PFS), while also improving overall survival (OS), objective response rate (ORR), disease control rate (DCR), and local control rate (LCR), as well as maintaining quality of life (QoL). In addition, the trial will systematically evaluate the safety profile and treatment-related toxicities associated with this regimen.",[60,28,61,62,63,64],"Hepatocellular Carcinoma","Oligometastases","Radiotherapy","Immunotherapy","Hepatic Artery Infusion Chemotherapy","2026-05-04",{"date":67,"type":39},"2026-05-08",{"date":69,"type":39},"2025-07-25",{"date":71,"type":21},"2029-07-25",{"name":73,"class":46},"Shandong Cancer Hospital and Institute",{"id":75,"slug":4,"hasResults":10,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":47},"100563889","NCT06622031","TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT","Transjugular Intrahepatic Portosystemic Shunt Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus: a Multicenter Phase II Study","Inclusion Criteria:\n\n1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;\n2. presence of PVTT with III-IV grade by Cheng's criteria;\n3. having PVTT induced portal hypertension;\n4. with or without PVTT induced acute variceal bleeding;\n5. metastases with limited five sites and no more two organs involved;\n6. Number of Intrahepatic tumors were no more than five;\n7. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;\n8. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;\n9. no history of other malignancies;\n10. agreed to participated in this clinical trial;\n11. Hemameba ≥3.0 x109\u002FL, neutrophil ≥1.5x109\u002FL, hemoglobin≥10.0 g\u002FL, platelet≥100x 109\u002FL, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml\u002Fmin.\n\nExclusion Criteria:\n\n1. recurrent HCC;\n2. PVTT at I-II grade by Cheng's criteria;\n3. age \\\u003C 18 years or \\> 75 years;\n4. advanced HCC with more than five metastases;\n5. Number of Intrahepatic tumors were more than five;\n6. no response to Lenvatinib;\n7. life expectancy less than 3 months.","75 Years",{"count":82,"type":21},42,[84],"NA","Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension, then the second is the tumor-caused death. It is vital to prevent the portal hypertension by PVTT.",[60,28,87],"Systemic Therapy",[89,33,90,91,32,92,93],"Advanced hepatocellular carcinoma","Sintilimab","Camrelizumab","Transjugular intrahepatic portosystemic shunt","Main trunk portal vein tumor thrombus","2025-01-09",{"date":96,"type":39},"2025-01-13",{"date":98,"type":39},"2024-10-01",{"date":100,"type":21},"2027-08-30",{"name":102,"class":46},"Sun Yat-sen University",""]