Sirolimus-Based Immunosuppression Therapy in OLT for Patients With HCC Exceeding Milan Criteria
A Prospective Randomised, Open-Labeled Study Comparing Sirolimus Versus FK506 In OLT for Patients With HCC Exceeding Milan Criteria
1 other identifier
interventional
220
1 country
1
Brief Summary
The purpose of this study is to evaluate the influence of sirolimus on outcome after OLT for HCC exceeding Milan criteria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hepatocellular-carcinoma
Started Aug 2007
Typical duration for phase_3 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 5, 2007
CompletedFirst Posted
Study publicly available on registry
November 6, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedNovember 6, 2007
October 1, 2007
November 5, 2007
November 5, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free survival
3-,5-year
Secondary Outcomes (1)
overall survival
3-,5-year
Study Arms (1)
2, III ,intervention
ACTIVE COMPARATORInterventions
given at an initial dose of 3 mg/m2, and adjusted over time to achieve steady-state whole-blood trough levels of approximately 5-8 ng/mL
Eligibility Criteria
You may qualify if:
- The major organ (liver,heart, lung and kidney) function after OLT was normal.
- Pathologically proved HCC before randomisation .
- Tumor exceeding the Milan criteria (one nodule ≤5 cm or 2-3 nodules all \<3 cm, without macroscopic vascular invasion and extrahepatic spreading).
- Signed, written informed consent.
You may not qualify if:
- Extrahepatic metastasis, nodal involvement, perioperative deaths (within 30 days after operation), and tumor thrombi in the proximal main trunk of the portal vein and / or vena cava
- History of cardiac disease.
- Active clinically serious infection (\>grade 2 Nation Cancer Institute NCI-CTCAE version 3.0).
- Known history of human immunodeficiency virus (HIV) infection.
- Any condition that is unstable or which could jeopardize the safety of the patient and his / her compliance in the study.
- Pregnant or breast-feeding patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Liver Cancer Institute and Zhongshan Hospital, Fudan University
Shanghai, 200032, China
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)
Study Officials
- STUDY DIRECTOR
Jia Fan, MD
Liver Cancer Institute and Zhongshan Hospital, Fudan University, 200032, Shanghai, China.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 5, 2007
First Posted
November 6, 2007
Study Start
August 1, 2007
Study Completion
August 1, 2013
Last Updated
November 6, 2007
Record last verified: 2007-10