For people ages 18 years and up
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- Patients who receive sirolimus (Rapamune) any time prior to randomization will be withdrawn from the study.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.
