De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma

Phase 2

Completed

• Conditions: Liver Carcinoma
• Interventions: Drug: Sirolimus

• Registration Number: NCT00328770
• Lead Sponsor: University of Alberta

Brief Summary

This study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.

Detailed Description

A total of 70 patients with HCC (mean age: 54.6 years, female/male: 12/58) received a liver transplant and were included in the study. Immunosuppression included de novo sirolimus, low-dose calcineurin inhibitor for 6 to 12 months, with short-course (3 months) or no steroids.

Study Timeline

• Study Start: 1996-12
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Study First Submitted: 2006-05-19
• Study First Submitted QC: 2006-05-19
• Study First Posted: 2006-05-22
• Results First Submitted: 2012-06-12
• Results First Submitted QC: 2012-08-27
• Results First Posted: 2012-10-01
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Adult patients with hepatocellular (HCC) carcinoma receiving liver transplant

Exclusion criteria:

• Patients less than 18 years of age

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sirolimus based immunosuppression	Sirolimus	Sirolimus given intravenously or orally to achieve serum level of 12-20ug/l

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Surviving at One and Four Years After Liver Transplant	1 & 4 years	Percent of Patients Surviving at One \& Four years after Liver Transplant was calculated
Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant	1 and 4 years	Percentage of Participants Surviving with no Evidence of Recurrent Hepatocellular Carcinoma at One and Four Years After Liver Transplant

Secondary Outcome Measures

Name	Time	Method
Sirolimus Toxicity/Intolerance	1 year	Sirolimus toxicity/intolerance requiring discontinuation of sirolimus

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada