RecruitingPhase 3NCT05557838
Study of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma
An Open-label, Multi-center Phase IIIb Study of Durvalumab and Tremelimumab as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma
Sponsor
AstraZeneca
Enrollment
210 participants
Start Date
Feb 22, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- Confirmed HCC based on histopathological findings from tumor tissue or radiologically findings
- 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 Criteria5
- 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 6 months
- HBV and HVC co-infection, or HBV and Hep D co-infection
Interventions
DRUGDurvalumab
Durvalumab IV (intravenous infusion)
DRUGTremelimumab
Tremelimumab IV (intravenous infusion)
Locations(32)
View Full Details on ClinicalTrials.gov
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NCT05557838
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