Status:
ACTIVE_NOT_RECRUITING
Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Lead Sponsor:
AstraZeneca
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief 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 sorafeni...
Detailed Description
The study population includes patients 18 years of age or older with advanced HCC, Barcelona Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C, and Child-Pugh A classificati...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2026
Estimated Enrollment :
1324 Patients enrolled
Trial Details
Trial ID
NCT03298451
Start Date
October 11 2017
End Date
August 27 2026
Last Update
October 15 2025
Active Locations (160)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Los Angeles, California, United States, 90048
2
Research Site
Orange, California, United States, 92868
3
Research Site
San Francisco, California, United States, 94158
4
Research Site
Washington D.C., District of Columbia, United States, 20007