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Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer

NCT02081755 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2026-01-27

No results posted yet for this study

Summary

This study is a prospective Phase IV study to determine if the use of Everolimus results in lower liver tumor recurrence and improved patient and graft survival after liver transplant for hepatocellular carcinoma (HCC). The immunosuppressive comparators will be Everolimus and Tacrolimus therapy compared to Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil/Azathioprine. Primary outcomes data is disease free survival (the time from randomization to HCC recurrence or death). Secondary outcomes are rate of recurrence of Hepatitis C, problems related to wound healing, hernia repair within the first 12 months, hepatic arterial thrombosis, renal function, acute cellular rejection, post-transplant diabetes, hypertension, and hyperlipidemia.

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

Everolimus

Everolimus Dosing: 1.5 mg BID (3.0 mg/day) for 12 months

DRUG

Tacrolimus

Tacrolimus Dosing: 0.05 mg/kg BID for 12 months

DRUG

Myfortic

Myfortic®: 360 mg to 1080 mg BID for 12 months

DRUG

CellCept

CellCept: 500 mg to 1500 mg BID for 12 months

DRUG

Imuran

0.5 mg/kg to 2 mg/kg QD for 12 months

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Goran Klintmalm, MD, PhD · Baylor Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02081755 on ClinicalTrials.gov