Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer

Enrolling by invitation · Phase 4

Conditions studied: Carcinoma, Hepatocellular

In brief

This study is a prospective Phase IV study to determine if the use of Everolimus results in lower liver tumor recurrence and improved patient and graft survival after liver transplant for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil/Azathioprine. Primary outcomes data is disease free survival (the time from randomization to HCC recurrence or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal function, acute cellular rejection, post-transplant diabetes, hypertension, and hyperlipidemia.

Key facts

Study ID: NCT02081755
Run by: Baylor Research Institute
People needed: 336
Starts: 2014-03-01
Expected to finish: 2027-03-01
Last updated by the study team: 2026-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

University of California at San Francisco — San Francisco, California, United States
Northwestern University School of Medicine — Chicago, Illinois, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
Mayo Clinic — Rochester, Minnesota, United States
Washington University School of Medicine — St Louis, Missouri, United States
Mount Sinai Medical Center — New York, New York, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
University of Tennessee- Methodist University Hospital — Memphis, Tennessee, United States
Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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