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

Primary Purpose

Liver Carcinoma

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Sirolimus
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Carcinoma focused on measuring liver transplant, hepatocellular carcinoma, sirolimus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sirolimus based immunosuppression

Arm Description

Sirolimus given intravenously or orally to achieve serum level of 12-20ug/l

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Sirolimus Toxicity/Intolerance
Sirolimus toxicity/intolerance requiring discontinuation of sirolimus

Full Information

First Posted
May 19, 2006
Last Updated
June 18, 2013
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT00328770
Brief Title
De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma
Official Title
De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma: Long-Term Outcomes and Side Effects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 1996 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Carcinoma
Keywords
liver transplant, hepatocellular carcinoma, sirolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sirolimus based immunosuppression
Arm Type
Experimental
Arm Description
Sirolimus given intravenously or orally to achieve serum level of 12-20ug/l
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
Rapamune
Intervention Description
Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l
Primary Outcome Measure Information:
Title
Percentage of Participants Surviving at One and Four Years After Liver Transplant
Description
Percent of Patients Surviving at One & Four years after Liver Transplant was calculated
Time Frame
1 & 4 years
Title
Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant
Description
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 Outcome Measure Information:
Title
Sirolimus Toxicity/Intolerance
Description
Sirolimus toxicity/intolerance requiring discontinuation of sirolimus
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients with hepatocellular (HCC) carcinoma receiving liver transplant Exclusion criteria: Patients less than 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman M Kneteman, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19192962
Citation
Treiber G. mTOR inhibitors for hepatocellular cancer: a forward-moving target. Expert Rev Anticancer Ther. 2009 Feb;9(2):247-61. doi: 10.1586/14737140.9.2.247.
Results Reference
derived

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

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