Overview

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

Status:
Unknown status
Trial end date:
2021-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Baylor Research Institute
Treatments:
Azathioprine
Everolimus
Mycophenolate mofetil
Mycophenolic Acid
Sirolimus
Tacrolimus