Sequential or Up-front Triple Treatment With Durvalumab, Tremelimumab and Bevacizumab for Non-resectable Hepatocellular Carcinoma (HCC) Patients
Recruiting now · Phase 2
Conditions studied: Hepatocellular Carcinoma
In brief
This is a randomized, open-label, multi-center, international, Phase II study to assess the efficacy and safety of sequential or up-front triple treatment with durvalumab, tremelimumab and bevacizumab for non-resectable hepatocellular carcinoma. Patients will be randomized in a 1:1 ratio to one of the following arms: Arm A: initial treatment with durvalumab plus tremelimumab followed by treatment escalation with the addition of bevacizumab upon radiological progression or in the absence of objective response Arm B: up-front treatment with durvalumab, tremelimumab and bevacizumab Patients will be stratified according to macrovascular invasion and etiology of liver disease (viral etiologies versus others).
Key facts
- Study ID
- NCT05844046
- Run by
- Enrico De Toni
- People needed
- 83
- Starts
- 2023-04-06
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2024-07-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Hospital of the University of Munich — Munich, Germany (enrolling)
- Klinikum Rechts der Isar of the Technical University Munich — Munich, Germany (enrolling)
- Würzburg University Hospital — Würzburg, Germany (enrolling)
Full record on ClinicalTrials.gov
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