Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

• Status: Recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy.

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

Details

• Lead Sponsor: AstraZeneca
• Treatments: Antibodies, Monoclonal; Durvalumab; Sorafenib; Tremelimumab

Criteria

Inclusion criteria

• HCC based on histopathological confirmation

• No prior systemic therapy for HCC

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

• Child-Pugh Score class A

• ECOG performance status of 0 or 1 at enrollment

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