NCT07490262

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

A Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy as First-line Treatment in Previously Untreated Patients With Unresectable or Metastatic Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 680 (estimated)
• Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	15 mg/kg intravenous infusion, administered on Day 1 of each 3-week treatment cycle
DRUG	Capecitabine	1000 mg/m² orally, administered on Days 1-14 of each 3-week treatment cycle, maximum 4 cycles.
DRUG	Oxaliplatin	85 mg/m² intravenous infusion, administered on Day 1 of each 3-week treatment cycle, maximum 4 cycles.
BIOLOGICAL	IBI310	1 mg/kg intravenous infusion, administered on Day 1 of each 6-week treatment cycle
BIOLOGICAL	Sintilimab	200 mg intravenous infusion, administered on Day 1 of each 3-week treatment cycle

Timeline

• Start date: 2026-03-27
• Primary completion: 2027-12-31
• Completion: 2030-12-31
• First posted: 2026-03-24
• Last updated: 2026-04-16

Locations

2 sites across 1 country: China