EUCTR2005-005362-36-BE进行中（未招募）1 期
A prospective randomised, open-labelled, trial comparing sirolimus- containing versus mTor-Inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma. - SiLVER
Regensburg University Medical Center0 个研究点目标入组 482 人开始时间: 2006年4月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 482
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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)
研究者
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