Clinical Trial

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

Enrolling by Invitation Phase 4
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2014-03-05; most recent amendment 2026-01-26.
Status change: Active, Not Recruiting → Enrolling by Invitation 2026-01-26
Status change: Recruiting → Active, Not Recruiting 2019-10-24
Trial Details
NCT Number NCT02081755
Lead Sponsor Baylor Research Institute
Conditions Carcinoma, Hepatocellular
Enrollment 336 participants
Start Date 2014-03
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-01-27