Ipilimumab N01 Combined With Sintilimab, Bevacizumab Biosimilar, and Hepatic Arterial Infusion Chemotherapy as Conversion Therapy for Unresectable Intermediate-Advanced Hepatocellular Carcinoma

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

NCT Number	NCT07560488
Lead Sponsor	Tianjin Medical University Cancer Institute and Hospital
Conditions	HCC - Hepatocellular Carcinoma, Conversion Therapy
Enrollment	43 participants
Start Date	2026-03-30
Primary Completion	2027-04 (estimated)
Study Completion	2028-04 (estimated)
Updated on ClinicalTrials.gov	2026-05-01