Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC
A Phase III, Randomized, Open-Label, Sponsor-Blinded, Multicenter Study of Durvalumab in Combination With Tremelimumab ± Lenvatinib Given Concurrently With TACE Compared to TACE Alone in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-3)
Sponsor: AstraZeneca
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression Free Survival (PFS) for Arm A vs Arm C
Time frame: Approximately 5 years
Secondary Endpoints
Overall Survival (OS) for Arm A vs Arm C
Progression Free Survival (PFS) for Arm B vs Arm C
Overall Survival (OS) for Arm B vs Arm C
Eligibility Criteria
Inclusion Criteria: * No evidence of extrahepatic disease * Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE * Child Pugh score class A * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment * Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria * Adequate organ and marrow function Exclusion Criteria: * History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardia arrhythmia * History of hepatic encephalopathy * Major portal vein thrombosis visible on baseline imaging * Uncontrolled arterial hypertension * Co-infection with HBV and HDV
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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