NCT04720716

A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC

A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 344 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, controlled, multicenter Phase III study to evaluate the effectiveness and safety of IBI310 combined with sintilimab and sorafenib in patients with locally advanced or metastatic HCC who have not previously received systemic therapy, are unsuitable for radical surgical resection or local treatment, or have had progressive disease after surgical resection or local treatment.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	IBI310	IBI310 IV d1, Q6W
DRUG	Sintilimab	sintilimab IV d1, Q3W
DRUG	Sorafenib	Sorafenib 400mg po

Timeline

• Start date: 2021-02-07
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-01-22
• Last updated: 2026-03-19

Locations

1 site across 1 country: China