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

• Conditions: iver transplantation in patients with hepatocellular carcinoma; MedDRA version: 9.1Level: LLTClassification code 10019695Term: Hepatic neoplasm

• Registration Number: EUCTR2007-003275-40-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-29
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified