Baylor Research Institute
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.
The study population will consist of approximately 336 patients (224 Everolimus and Tacrolimus and 112 Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil/Azathioprine). Initial screening criteria will include the presence of hepatocellular carcinoma in patients 18 years or older who are candidates to receive a primary orthotopic liver transplant (from deceased or living donor). Within 7 - 12 days post-transplant, patients will be re-evaluated for eligibility for randomization. The criteria include: pre-transplant imaging that shows HCC disease exceeding Milan criteria; pathology review for…
Screening Inclusion Criteria: * Have a diagnosis of hepatocellular carcinoma (HCC) and high risk for HCC recurrence * Able to provide written informed consent * Male and female patients of any race, 18 years or older * De novo recipients of a primary orthotopic liver transplant from a deceased or living donor * Patients willing to comply with study requirements * Women of child-bearing potential (WOCBP) must agree to use an effective method(s) of contraception during treatment and during the post treatment follow-up period Screening Exclusion Criteria: * Past or present malignancy within th…
Everolimus Dosing: 1.5 mg BID (3.0 mg/day) for 12 months
Tacrolimus Dosing: 0.05 mg/kg BID for 12 months
Myfortic®: 360 mg to 1080 mg BID for 12 months
CellCept: 500 mg to 1500 mg BID for 12 months
0.5 mg/kg to 2 mg/kg QD for 12 months