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

Official Title:

A 36 Month Multi-center, Open Label, Randomized, Comparator Study to Evaluate the Efficacy and Safety of Everolimus Immunosuppression Treatment in Liver Transplantation for Hepatocellular Carcinoma Exceeding Milan Criteria

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 4 Interventional 18 Years and older Baylor Research Institute 013-307
NCT02081755
Enrolling patients

Study Design:


Principal Investigator

Professor of Clinical Surgery 
Division of Transplant Surgery
Associate Program Director,
UCSF General Surgery Residency Program

Clinical Research Coordinator

UCSF Medical Center at Parnassus
(415) 514-0192 Phone

Trial 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. 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.

Eligibility

Screening Inclusion Criteria:
  • 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
Screening Exclusion Criteria:
  • 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.
  • 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
Randomization Screening Inclusion Criteria :
- For patients with a history of any hepatic vessel thrombosis, occlusion, stent placement,
or major revision of liver vessels, must have a Doppler ultrasound prior to randomization
to rule out any hepatic vessel complication, including hepatic arterial thrombosis (HAT).
Randomization Exclusion Criteria:
  • 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
  • Consideration by the investigator, for any reason, that the subject is an unsuitable
    candidate to receive everolimus or be randomized into the study.

Detailed Description

The study population will consist of approximately 336 patients (224 Everolimus and
Tacrolimus and 112 Tacrolimus and Mycophenolic acid/Mycophenolate Mofetil). Initial screening
criteria will includethe presence of hepatocellular carcinoma in the explant as determ
patients 18 years or older who are candidates to receive a primary orthotopic liver
transplant (from deceased or living donor). Within 7 - 12 days post-transplant, patients will
be re-evaluated for eligibility for randomization. The criteria include: pre-transplant
imaging that shows HCC disease exceeding Milan criteria; pathology review for tumor burden
and/or presence of microvascular invasion; AFP >200IU/mL; pre-transplant ablation or
resection with HCC recurrence; progression or new tumors; evaluation to rule out any hepatic
vessel complication.
Subjects will remain in study treatment until Month 12 at which time the subject and
investigator will determine the preferred immunosuppressive regimen. Subjects will be
followed for an additional 24 months for outcome data as described above.

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 2/13/2018. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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