NCT02081755
Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer
Enrolling by Invitation
PHASE4Ages 18+InterventionalTreatmentBaylor Research InstituteInvestigator-initiated
~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
Where it's being run
9 sites across 9 statesCalifornia1
Illinois1
Kansas1
Minnesota1
Missouri1
New York1
Pennsylvania1
Tennessee1
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
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
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