Sirolimus-based Immunosuppression Treatment Regimen for Liver Transplantation

• Status: Not yet recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southern Medical University, China
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Nanfang Hospital of Southern Medical University
• Treatments: Everolimus; Mycophenolic Acid; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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