Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
About the study
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
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Hepatocellular Carcinoma
Age (in years)
18 - 100
Phase
Phase 3
Participants needed
1324
Est. Completion Date
Aug 27, 2024
Treatment type
Interventional
Sponsor
AstraZeneca
ClinicalTrials.gov identifier
NCT03298451
Study number
D419CC00002
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