[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597712":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":38,"centralContacts":42,"locations":48,"responsibleParty":64,"collaborators":23,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":23,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":23,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":23,"overallStatus":50,"whyStopped":23,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Shandong Cancer Hospital and Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Hepatic artery infusion chemotherapy (HAIC): On Day 1 of each cycle, initiated via a hepatic arterial catheter or pump and completed over 2-3 days, as follows: oxaliplatin 130 mg\u002Fm², leucovorin 200 mg\u002Fm², fluorouracil 400 mg\u002Fm² as a bolus, followed by fluorouracil 2,400 mg\u002Fm² by continuous infusion over 46 h (every 3 weeks for up to four cycles) Drug: Bevacizumab (15 mg\u002Fkg, IV, every 3 weeks) Drug: Iparomlimab\u002Ftuvonralimab (7.5 mg\u002Fkg, IV, every 3 weeks, administered sequentially after bevacizumab) Radiation: Stereotactic Body Radiotherapy (SBRT), total dose of 25-40 Gy in 5 fractions over 1-2 weeks, targeting intrahepatic tumors, portal vein tumor, and\u002For limited extrahepatic oligometastatic lesions",[13,14,15,16],"Drug: Anti-VEGF","Drug: Immunotherapy","Radiation: Local Therapy","Procedure: hepatic arterial infusion chemotherapy (HAIC)",[18,24,28,33],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Anti-VEGF","Drug: Bevacizumab (15 mg\u002Fkg, IV, every 3 weeks)",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Immunotherapy","Iparomlimab\u002Ftuvonralimab (7.5 mg\u002Fkg, IV, every 3 weeks, administered sequentially after bevacizumab)",[9],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"RADIATION","Local Therapy","Stereotactic Body Radiotherapy (SBRT), total dose of 25-40 Gy in 5 fractions over 1-2 weeks, targeting intrahepatic tumors, portal vein tumor, and\u002For limited extrahepatic oligometastatic lesions",[9],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":23},"PROCEDURE","hepatic arterial infusion chemotherapy (HAIC)","On Day 1 of each cycle, HAIC using the HAIC-FO regimen will be initiated via a hepatic arterial catheter or pump and completed over 2-3 days, as follows: oxaliplatin 130 mg\u002Fm², leucovorin 200 mg\u002Fm², fluorouracil 400 mg\u002Fm² as a bolus, followed by fluorouracil 2,400 mg\u002Fm² by continuous infusion over 46 h. HAIC may be administered every 3 weeks for up to four cycles.",[9],[39],{"name":40,"affiliation":5,"role":41},"Jinbo Yue, Doctor","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":23,"email":47},"Jinbo Yue, doctor","CONTACT","0531-67626442","jbyue@sdfmu.edu.cn",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":23,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Jinan","Shandong","China","CN",{"type":56,"coordinates":57},"Point",[58,59],116.99722,36.66833,{"lat":59,"lon":58},[62,63],{"name":44,"role":45,"phone":46,"phoneExt":23,"email":47},{"name":40,"role":45,"phone":23,"phoneExt":23,"email":47},{"type":41,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Jinbo Yue","Director of Radiation Oncology Department","100597712","phase-2-bits-to-hcc-study-haiciparomlimabtuvonralimab--bevacizumab--sbrt-for-bclc-c-hcc-with-pvtt-andor-oligometastases-100597712",false,"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","ALL","18 Years","70 Years",{"count":78,"type":79},54,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","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.",[85,86,87,88,25,89],"Hepatocellular Carcinoma","Portal Vein Tumor Thrombus","Oligometastases","Radiotherapy","Hepatic Artery Infusion Chemotherapy","2026-05-04",{"date":92,"type":93},"2026-05-08","ACTUAL",{"date":95,"type":93},"2025-07-25",{"date":97,"type":79},"2029-07-25",{"name":5,"class":6},1]