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NCT02081755

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

Enrolling by Invitation
PHASE4Ages 18+InterventionalTreatment
Baylor Research Institute
~336 participants
Updated 2026-01-27 on ClinicalTrials.gov
What's tested:EverolimusTacrolimusMyforticCellCeptImuran

At a glance

Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease free survival (DFS) defined as the time from randomization to the time of tumor recurrence or death, whichever occurs first.
Measured over Through Month 36

Conditions

Carcinoma, Hepatocellular

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NCT02081755

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baylor University Medical Center

    Dallas, Texasno site contact published

  • Mayo Clinic

    Rochester, Minnesotano site contact published

  • Mount Sinai Medical Center

    New York, New Yorkno site contact published

  • Northwestern University School of Medicine

    Chicago, Illinoisno site contact published

  • University of California at San Francisco

    San Francisco, Californiano site contact published

  • University of Kansas Medical Center

    Kansas City, Kansasno site contact published

  • University of Pennsylvania

    Philadelphia, Pennsylvaniano site contact published

  • University of Tennessee- Methodist University Hospital

    Memphis, Tennesseeno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Have a diagnosis of hepatocellular carcinoma (HCC) and high risk for HCC recurrence
Able to provide written informed consent
Male and female patients of any race, 18 years or older
De novo recipients of a primary orthotopic liver transplant from a deceased or living donor
Patients willing to comply with study requirements
Women of child-bearing potential (WOCBP) must agree to use an effective method(s) of contraception during treatment and during the post treatment follow-up period

Exclusion

Past or present malignancy within the last 5 years.
Severe infection considered by the local site investigator to be unsafe for study participation.
Use of other investigational drugs at the time of screening or within the last 30 days.
Patients scheduled for a combined transplant (such as liver-kidney), or having a previous solid organ, bone marrow, or autologous islet cell transplant.
Recipients of donor/recipient ABO incompatible grafts.
Recipients of organs from human immunodeficiency virus (HIV) or HBsAg positive donors.
Macrovascular tumor invasion.
Proteinuria greater than 2 grams/24 hours.
Conditions which can result in impaired absorption, distribution, metabolism or excretion of the study treatment.
Patients with non-infectious pneumonitis.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
Women of child-bearing potential (WOCBP) not practicing an effective method(s) of contraception.
Patients who receive sirolimus (Rapamune®) as part of their transplant immunosuppression regimen
Patients who receive sirolimus (Rapamune) any time prior to randomization will be withdrawn from the study.
Patients who develop clinically significant systemic infections requiring active use of IV antibiotics any time prior to randomization.
Wound healing problem, per Investigator's assessment, that would make the patient ineligible for study randomization
Confirmed presence of a thrombosis in a major hepatic artery(s), major hepatic vein(s), portal vein or inferior vena cava via Doppler ultrasound or other imaging obtained prior to randomization.
Proteinuria greater than 2 grams/24 hours.
Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive everolimus or be randomized into the study.

What this trial measures

  • Disease free survival (DFS) defined as the time from randomization to the time of tumor recurrence or death, whichever occurs first.Through Month 36