ew immunosuppressive treatments to reduce the rate of recurrence of hepatocellular carcinoma after liver transplantation - CT-MV-01-2007

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点开始时间: 2008年7月29日最近更新: 2014年2月24日

试验速览

暂无简介。

•Patients undergoing liver transplantation because of HCC
•tumor that at the pathological examination of the native liver removed at transplantation results beyond the Milan criteria
•presence of tumor microvascular invasion revealed by the pathological examination of the native liver removed at transplantation
•preoperative serum alphafetoprotein levels above 50 ng/mL
•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) no
•F.1.3.1 Number of subjects for this age range

•1)graft dysfunction that contraindicates changes from the usual immunosuppressive schedule based on calcineurin inhibitors
•2)women in fertile age that do not accept contraception
•3)known hypersensitivity to sirolimus or to m-TOR inhibitors;
•4)critical patients that are judged by the experimenter as not suitable to be include in the study;
•5)use of experimental drugs in the two months before the enrolment in the study.
•6)patients who can not comply with the procedures associated with the protocol or can not express in writing the informed consent.

发起方

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI