Study of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma

• Status: Not yet recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, open label, multi-center, interventional study to assess the safety and efficacy of Druvalumab plus Tremelimumab as first-line treatment in Chinese patients with unresectable hepatocellular carcinoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Durvalumab; Tremelimumab

Criteria

Inclusion Criteria:

• HCC based on histopathological confirmation

• No prior systemic therapy for HCC

• Barcelona Clinic Liver Cancer (BCLC) stage B (not eligible for locoregional therapy) or stage C

• Child-Pugh Score class A or B

• ECOG performance status (PS) of 0-2 at enrollment (Child-Pugh Score class A and ECOG PS of 0-1 will be enrolled in cohort 1 and Child-Pugh Score class B or ECOG PS of 2 will be enrolled in cohort 2)

• At least 1 measurable lesion per RECSIT 1.1 guidelines

Exclusion Criteria:

• Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy

• Clinically meaningful ascites

• Main portal vein tumor thrombosis

• Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months

• HBV and HVC co-infection, or HBV and Hep D co-infection