Status:
ACTIVE_NOT_RECRUITING
Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC
Lead Sponsor:
AstraZeneca
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
Brief Summary
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma
Detailed Description
This is a Phase III, parallel, randomized, open-label, sponsor-blinded, 3-arm, multicenter, international study assessing the efficacy and safety of durvalumab + tremelimumab + TACE with or without le...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2027
Estimated Enrollment :
760 Patients enrolled
Trial Details
Trial ID
NCT05301842
Start Date
March 28 2022
End Date
February 26 2027
Last Update
January 15 2025
Active Locations (171)
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1
Research Site
Birmingham, Alabama, United States, 35233
2
Research Site
Mobile, Alabama, United States, 36607
3
Research Site
Yuma, Arizona, United States, 85364
4
Research Site
Glendale, California, United States, 91204