Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma

The purpose of this study is to determine the safety and efficacy of sirolimus-based immunosuppressive therapy in patients following orthotopic liver transplantation (OLT) for hepatocellular carcinoma (HCC), with regard to HCC recurrence-free patient survival.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

1. Age 18 years and older
2. Histologically proven HCC before randomisation
3. Signed, written informed consent

Exclusion Criteria:

1. Multiple-organ recipients.
2. Known hypersensitivity to sirolimus or its derivatives.
3. Hyperlipidemia refractory to optimal medical management. (cholesterol \>300 mg/dL; triglycerides \>350 mg/dL).\*
4. Evidence of significant local or systemic infection.
5. Known HIV-positive patients.\*
6. Platelets \<75,000/cubic mm.\*
7. Women of child-bearing potential not willing to take contraception.
8. Patients with non-HCC malignancies within the past 5 years,excluding successfully treated squamous cell carcinoma and basal cell carcinoma of the skin.
9. Extrahepatic HCC tumor manifestation
10. Patients with a psychologic, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
11. Patients under guardianship (e.g. individuals who are not able to freely give their informed consent).

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