NCT07560488 Ipilimumab N01 Combined With Sintilimab, Bevacizumab Biosimilar, and Hepatic Arterial Infusion Chemotherapy as Conversion Therapy for Unresectable Intermediate-Advanced Hepatocellular Carcinoma
| NCT ID | NCT07560488 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | HCC - Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2026-03-30 |
| Primary Completion | 2027-04 |
Trial Parameters
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Brief Summary
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. This 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
Eligibility Criteria
Inclusion Criteria: * Written informed consent must be signed prior to initiation of any study-related procedures; * Age ≥ 18 years, and ≤75 years, regardless of gender; * Clinically diagnosed or histologically/cytologically confirmed hepatocellular carcinoma (HCC) according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition); * No prior anti-tumor therapy for HCC before study treatment * Unresectable locally advanced or advanced HCC (CNLC Stage IIa-IIIb). * Expected overall survival \> 6 months. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Child-Pugh score class A or B * Adequate organ function defined by the following laboratory parameters: 1. Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L without granulocyte colony-stimulating factor support within 14 days; 2. Platelet count ≥ 80×10⁹/L without transfusion within 14 days; 3. Hemoglobin \> 9 g/dL without transfusion or erythropoietin within 14 days; 4. Total biliru
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