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

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 the last 5 years. * Severe infection considered by the local site investigator to be unsafe for study participation. * Use of other investigational drugs at the time of screening or within the last 30 days. * Patients scheduled for a combined transplant (such as liver-kidney), or having a previous solid organ, bone marrow, or autologous islet cell transplant. * Recipients of donor/recipient ABO incompatible grafts. * Recipients of organs from human immunodeficiency virus (HIV) or HBsAg positive donors. * Macrovascular tumor invasion. * Proteinuria greater than 2 grams/24 hours. * Conditions which can result in impaired absorption, distribution, metabolism or excretion of the study treatment. * Patients with non-infectious pneumonitis. * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test. * Women of child-bearing potential (WOCBP) not practicing an effective method(s) of contraception. * Patients who receive sirolimus (Rapamune®) as part of their transplant immunosuppression regimen Randomization Screening Inclusion Criteria : \- For patients with a history of any hepatic vessel thrombosis, occlusion, stent placement, or major revision of liver vessels, must have a Doppler ultrasound prior to randomization to rule out any hepatic vessel complication, including hepatic arterial thrombosis (HAT). Randomization Exclusion Criteria: * Patients who receive sirolimus (Rapamune) any time prior to randomization will be withdrawn from the study. * Patients who develop clinically significant systemic infections requiring active use of IV antibiotics any time prior to randomization. * Wound healing problem, per Investigator's assessment, that would make the patient ineligible for study randomization * Confirmed presence of a thrombosis in a major hepatic artery(s), major hepatic vein(s), portal vein or inferior vena cava via Doppler ultrasound or other imaging obtained prior to randomization. * Proteinuria greater than 2 grams/24 hours. * Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive everolimus or be randomized into the study.