drugset / Trial / NCT04720716

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

NCT04720716

Phase 3 Completed 344 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-02-07
Primary completion
2025-12-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject IBI310 Monoclonal antibody Intravenous
Subject Sintilimab Monoclonal antibody Intravenous
Comparator Sorafenib Small molecule 400 mg Oral