drugset / Trial / NCT07560488

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

NCT07560488 ↗

NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2026-03-30
Primary completion
2027-04
Completion
2028-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Subject Ipilimumab Monoclonal antibody 3 mg/kg Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous