Study on the Safety and Effectiveness of Everolimus in Liver Transplant Patients with Liver Cancer

Inclusion Criteria

• Diagnosed with hepatocellular carcinoma (HCC) and at high risk for the cancer returning.
• Able to give written consent to participate.
• Male and female patients, 18 years or older.
• Receiving a first-time liver transplant from a deceased or living donor.
• Willing to follow study requirements.
• Women who can become pregnant must agree to use effective birth control during the study and follow-up period.

Exclusion Criteria

• Have had another cancer in the past 5 years.
• Have a severe infection that makes participation unsafe.
• Taking other experimental drugs recently.
• Scheduled for a combined transplant or have had a previous organ transplant.
• Receiving a liver from an incompatible donor or a donor with certain infections.
• Have large blood vessel tumor invasion.
• Have high levels of protein in urine.
• Have conditions affecting drug absorption or processing.
• Have non-infectious lung inflammation.
• Pregnant or breastfeeding women.
• Women not using effective birth control.
• Taking sirolimus (Rapamune®) as part of transplant treatment.

Randomization Screening Inclusion Criteria:

• Must have a Doppler ultrasound to check for liver blood vessel issues if there's a history of certain liver vessel problems.

Randomization Exclusion Criteria:

• Taking sirolimus (Rapamune) before randomization.
• Have serious infections needing IV antibiotics before randomization.
• Have wound healing issues that prevent study participation.
• Have confirmed blood clots in major liver vessels before randomization.
• Have high levels of protein in urine.
• Considered unsuitable for Everolimus or study participation by the investigator.