drugset
drugset / Trial / NCT07490262

A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment.

NCT07490262 ↗

Phase 2/3 Recruiting 680 enrolled Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a randomized, controlled, open-label, multicenter, seamless Phase II/III trial designed to evaluate the efficacy and safety of the combination regimen of IBI310 and sintilimab in participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who are: (1) treatment-naive to systemic therapy; and (2) either unsuitable for curative-intent surgical resection or local therapy, or have experienced disease progression following prior surgical resection or local therapy.

Timeline

Start
2026-03-27
Primary completion
2027-12-31
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject IBI310 Monoclonal antibody 1 mg/kg Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background Sintilimab Monoclonal antibody 200 mg Intravenous

Indications

hepatocellular carcinoma