NCT05363722

A Clinical Study to Observe the Effectiveness and Safety of IBI310, Bevacizumab Combined With Sintilimab in the Treatment of Advanced Hepatocellular Carcinoma

A Randomized, Open-label, Multicenter Phase Ib Clinical Study to Observe the Effectiveness and Safety of Different Doses of IBI310,Bevacizumab Combined With Sintilimab in the First-line Treatment of Advanced Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, multicenter Phase Ib study to evaluate the effectiveness and safety of different doses of IBI310, bevacizumab combined with sintilimab 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 progressive disease after surgical resection or local treatment.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	IBI310（0.5mg/kg）	IBI310 0.5mg/kg IV d1 Q6W
DRUG	IBI310（0.3mg/kg）	IBI310 0.3mg/kg IV d1 Q6W
DRUG	sintilimab	sintilimab 200 mg IV d1 Q3W
DRUG	bevacizumab	bevacizumab 15 mg/kg IV d1，Q3W

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-04-01
• Completion: 2024-04-01
• First posted: 2022-05-06
• Last updated: 2022-05-06