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Clinical Trial Summary

Immunotherapy can safely downstage patients and achieve durable systemic disease control to improve clinical outcomes in HCC patients undergoing liver transplant.

Clinical Trial Description

ESR-20-21010 is a single-arm, open-label, Phase II, multicenter clinical trial designed to evaluate the safety and efficacy of durvalumab and tremelimumab for the treatment of hepatocellular carcinoma (HCC) patients who have cirrhosis or portal hypertension and are listed for a liver transplant. The key eligibility requirements include HCC within UCSF criteria, Child-Pugh score of up to 7, and ECOG PS of 0 or 1. Patients will be treated with the immunotherapy combination for up to 4 months. After a minimum 28 day washout, they will undergo locoregional therapy per institutional standards. Eventually, after a minimum 72-day washout from the end of immunotherapy, they will undergo liver transplant. The primary endpoint is proportion of patients experiencing post-transplant rejection (within 30 days of transplant). A total of 30 patients are to be enrolled, to allow at least 20 transplants for adequate primary endpoint analysis. An interim analysis after 10 patients will be performed to ensure safety. If there are untoward safety signals, study modification/discontinuation will be discussed. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05027425
Study type Interventional
Source University of Cincinnati
Contact Davendra Sohal, MD
Phone (513) 558-2361
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date October 1, 2021
Completion date October 1, 2030

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