De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma
1 other identifier
interventional
70
1 country
1
Brief Summary
This study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 1996
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 19, 2006
CompletedFirst Posted
Study publicly available on registry
May 22, 2006
CompletedResults Posted
Study results publicly available
October 1, 2012
CompletedJune 24, 2013
June 1, 2013
9.3 years
May 19, 2006
June 12, 2012
June 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
1 and 4 years
Secondary Outcomes (1)
Sirolimus Toxicity/Intolerance
1 year
Study Arms (1)
Sirolimus based immunosuppression
EXPERIMENTALSirolimus given intravenously or orally to achieve serum level of 12-20ug/l
Interventions
Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l
Eligibility Criteria
You may qualify if:
- Adult patients with hepatocellular (HCC) carcinoma receiving liver transplant
You may not qualify if:
- Patients less than 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alberta
Edmonton, Alberta, T6G 2B7, Canada
Related Publications (1)
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.
PMID: 19192962DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Norman Kneteman
- Organization
- Liver Transplant Program, University of Alberta Hospitals
Study Officials
- PRINCIPAL INVESTIGATOR
Norman M Kneteman, MD
University of Alberta
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-zone Clinical Section Chief, Transplants/NARP
Study Record Dates
First Submitted
May 19, 2006
First Posted
May 22, 2006
Study Start
December 1, 1996
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
June 24, 2013
Results First Posted
October 1, 2012
Record last verified: 2013-06