A 36 Month Multi-center, Open Label, Randomized, Comparator Study to Evaluate the Efficacy and Safety of Everolimus Immunosuppression Treatment in Liver Transplantation for Hepatocellular Carcinoma Exceeding Milan Criteria

NCT02081755 Phase 4 ENROLLING_BY_INVITATION

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.

Details

Lead sponsor	Baylor Research Institute
Phase	Phase 4
Status	ENROLLING_BY_INVITATION
Enrolment	336
Start date	2014-03
Completion	2027-03

Conditions

• Carcinoma, Hepatocellular

Interventions

• Everolimus
• Tacrolimus
• Myfortic
• CellCept
• Imuran

Primary outcomes

• Disease free survival (DFS) defined as the time from randomization to the time of tumor recurrence or death, whichever occurs first. — Through Month 36

Countries

United States