Sirolimus-based Immunosuppression Treatment Regimen for Liver Transplantation
1 other identifier
interventional
130
1 country
3
Brief Summary
This is a multicenter, open-label, randomized, controlled clinical trial, in order to compare sirolimus-based (tacrolimus-free) versus tacrolimus-based (sirolimus-free) immunosuppression regimen for Hepatocellular Carcinoma (HCC) patients after liver transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2018
Longer than P75 for phase_2
3 active sites
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
First Submitted
Initial submission to the registry
March 29, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedApril 18, 2018
April 1, 2018
5.1 years
March 29, 2018
April 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HCC recurrence free survival
The primary endpoint is defined as HCC recurrence-free time interval between the date of liver transplantation and the date of HCC recurrence or death; patients who are alive and recurrence-free at the end of month 36 will be censored at the time of their last follow-up date. HCC recurrence can be determined during the entire follow-up period.
Randomization to Month 36
Secondary Outcomes (5)
Overall survival
Randomization to Month 36
Incidence of acute rejection
Randomization to Month 36
Treatment failures defined as introduction of Tacrolimus to experimental group
Randomization to Month 36
Graft survival
Randomization to Month 36
Incidence of adverse events
Randomization to Month 36
Study Arms (2)
Tacrolimus-based group
ACTIVE COMPARATORTacrolimus-based immunosuppression regimen: Tacrolimus+MMF and/or steroids
Sirolimus-based group
EXPERIMENTALSirolimus-based immunosuppression regimen: Tacrolimus (Tacrolimus elimination 30 (± 5) days post LT)+Sirolimus+MMF and/or steroids
Interventions
Tacrolimus will be started between 3 and 7 days post-transplantation and continued after randomization at a dose of 1.0 mg twice a day (bid, 2 mg daily dose). The tacrolimus trough level is measured twice a week for 1 month, followed by trough level once a month thereafter. Tacrolimus trough levels are targeted to be maintained at 8-15ng/ml until Month 6. After Month 6, the dose will be adjusted over time to maintain steady-state tacrolimus trough blood levels of approximately 5-10 ng/mL.
Tacrolimus will be started between 3 and 7 days post-transplantation at a dose of 1.0 mg twice a day (bid, 2 mg daily dose) for 30 (± 5) days and eliminated when randomization is done.
Within 24 hours of randomization, sirolimus will be started at a dose of 2.0 mg once a day. The sirolimus trough level is measured twice a week for 1 month, followed by trough level once a month thereafter. The dose will be adjusted over time to maintain steady-state sirolimus trough blood levels of approximately 4-10 ng/mL.
For patients in both groups, MMF and/or steroids are initiated at or prior to the time of liver transplantation according to local practice. Steroids reduction is encouraged by 3 months post liver transplantation.
Eligibility Criteria
You may qualify if:
- Recipients who are 18-65 years of age
- Histologically proven HCC before randomization
- Recipients who have been initiated on an immunosuppressive regimen that contains tacrolimus, 3-7 days post-transplantation
- Allograft is functioning at an acceptable level by the time of randomization as defined by protocol specific laboratory values
- Ability and willingness to provide written informed consent and adhere to study regimen
You may not qualify if:
- Patients with non-HCC malignancies within the past 5 years
- Patients who are multiple-organ recipients
- Patients who are known HIV-positive patients
- Patients who have received mTOR inhibitors prior to day 30 after liver transplantation
- Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients
- Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study drug
- Patients with a psychologic, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510282, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
First Affiliated Hospital, Sun Yat-Sen University
Guanzhou, Guangdong, 510080, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kebo Zhong, M.D
Department of Heptobiliary Surgery II, Zhujiang Hospital, Southern Medical University, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Post-doctoral Fellow
Study Record Dates
First Submitted
March 29, 2018
First Posted
April 18, 2018
Study Start
May 1, 2018
Primary Completion
May 31, 2023
Study Completion
May 31, 2023
Last Updated
April 18, 2018
Record last verified: 2018-04