A prospective randomised, open-labelled, trial comparing sirolimus- containing versus mTor-Inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma. - SiLVER
- Conditions
- Prophylaxis against liver transplant rejection in patients undergoing liver transplantation for hepatocellular carcinoma (HCC)MedDRA version: 8.1Level: LLTClassification code 10050434
- Registration Number
- EUCTR2005-005362-36-BE
- Lead Sponsor
- Regensburg University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 482
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.
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
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 tumour manifestation in HCC patients
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)
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