NCT03794440

A Study to Evaluate the Efficacy and Safety of Sintilimab in Combination With IBI305 (Anti-VEGF Monoclonal Antibody) Compared to Sorafenib as the First-Line Treatment for Advanced Hepatocellular Carcinoma.

A Randomized, Open-label，Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Sintilimab and IBI305 Compared to Sorafenib in the First-Line Treatment of Patients With Advanced Hepatocellular Carcinoma. （ORIENT-32）

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 595 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the safety, tolerability and effectiveness of Sintilimab in combination with IBI305 in patients with HCC as the first-line treatment compared with Sorafenib. This study is a randomised, Open-label，Multi-center Study. The primary endpoint is overall survival.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab	200mg IV d1， Q3W
DRUG	IBI305	15mg/kg IV d1， Q3W
DRUG	Sorafenib	400mg PO BID

Timeline

• Start date: 2019-02-11
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2019-01-07
• Last updated: 2021-01-22

Locations

1 site across 1 country: China