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

University of Alberta70 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Carcinoma

Interventions

SirolimusDRUG

Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients with hepatocellular (HCC) carcinoma receiving liver transplant Exclusion criteria: * Patients less than 18 years of age

Locations (1)

University of Alberta

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

Percentage of Participants Surviving at One and Four Years After Liver Transplant

Percent of Patients Surviving at One \& Four years after Liver Transplant was calculated

Time frame: 1 & 4 years

Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant

Percentage of Participants Surviving with no Evidence of Recurrent Hepatocellular Carcinoma at One and Four Years After Liver Transplant

Time frame: 1 and 4 years

Secondary Outcomes

Sirolimus Toxicity/Intolerance

Sirolimus toxicity/intolerance requiring discontinuation of sirolimus

Time frame: 1 year

Data from ClinicalTrials.gov

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