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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003275-40-IT

Enrollment

Registered

2008-07-29

Start date

2008-07-29

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver transplantation in patients with hepatocellular carcinoma MedDRA version: 9.1 Level: LLT Classification code 10019695 Term: Hepatic neoplasm

Interventions

Trade Name: RAPAMUNE Pharmaceutical Form: Coated tablet INN or Proposed INN: Sirolimus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Reduce the rate of tumor recurrence in patients who undergo liver transplantation (LT) because of hepatocellular carcinoma (HCC) by employing an immunosuppressant drug with antiproliferative properties: SIROLIMUS (RAPAMYCIN).;Secondary Objective: ConfIrm the efficacy of sirolimus employed in a calcinuerin inhibitors-free regimen in preventing rejection after liver transplantation.;Primary end point(s): HCC recurrence	—

Measure

Time frame

Main Objective: Reduce the rate of tumor recurrence in patients who undergo liver transplantation (LT) because of hepatocellular carcinoma (HCC) by employing an immunosuppressant drug with antiproliferative properties: SIROLIMUS (RAPAMYCIN).;Secondary Objective: ConfIrm the efficacy of sirolimus employed in a calcinuerin inhibitors-free regimen in preventing rejection after liver transplantation.;Primary end point(s): HCC recurrence

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026