A PROSPECTIVE RANDOMISED, OPEN-LABELED, TRIAL COMPARING SIROLIMUS-CONTAINING VERSUS mTOR-INHIBITOR-FREE IMMUNOSUPRESSION IN PATIENTS UNDERGOING LIVER TRANSPLANTATION FOR HEPATOCELLULAR CARCINOMA - SiLVER

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 482

Inclusion Criteria

Deceased Donor Liver Transplantation
The study includes all patients eligible for OLT as outlined by each of the participating
centers fulfilling the following criteria:

1. Age 18 years and older
2. Histologically proven HCC before randomisation*
3. Signed, written informed consent
*Individual patients who were treated pre-OLT for histologically proven HCC by for example chemoembolisation, radiofrequency ablation, or percutaneous ethanol installation, may show tumor reduction, or even complete necrosis. If there is complete tumor necrosis, histologic confirmation of HCC-post OLT will not be possible. In these cases, patients with a pretransplant histologic diagnosis of HCC may still be included in the study. However, patients with a complete biological tumor response will be down-staged and therefore stratified into the group considered within Milan criteria. In all patients with a pre-OLT histologic proof of HCC, and an incomplete tumor response following pretreatment, stratification will be solely performed according to the final postoperative histology.

Living-related liver transplantation
The study will also include living-related liver transplants (LRLT) performed in HCC
recipients. Inclusion criteria 1-3 (listed above) will apply in the same way.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 psychologic, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule
11. Patients under guardianship (e.g. patients who are not able to freely give their informed consent)
12. Patients receiving mTOR inhibitors prior to day 29 post-OLT.

* Based on the last data available before randomisation.
** Including tumor formations found in the extrahepatic portal vein.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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