Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Regensburg
• Treatments: Azathioprine; Cyclosporine; Cyclosporins; Everolimus; Prednisolone; Sirolimus; Tacrolimus

Criteria

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).