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

Part of paid clinical trials in San Francisco, California.

Sponsor
Baylor Research Institute
Study ID
NCT02081755
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Carcinoma, Hepatocellular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Everolimus — DRUG
    Everolimus Dosing: 1.5 mg BID (3.0 mg/day) for 12 months
  • Tacrolimus — DRUG
    Tacrolimus Dosing: 0.05 mg/kg BID for 12 months
  • Myfortic — DRUG
    Myfortic®: 360 mg to 1080 mg BID for 12 months
  • CellCept — DRUG
    CellCept: 500 mg to 1500 mg BID for 12 months
  • Imuran — DRUG
    0.5 mg/kg to 2 mg/kg QD for 12 months

Study Details

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.

Key Dates

Start date
Mar 31, 2014
Status verified
Jan 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
336 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Everolimus and Tacrolimus
    Everolimus Dosing: 1.5 mg BID (3.0 mg/day) Tacrolimus Dosing: 0.05 mg/kg BID
  • Active Comparator: Tacrolimus and Myfortic or CellCept or Imuran
    Myfortic: 360 mg to 1080 mg BID OR CellCept: 500 mg to 1500 mg BID OR Imuran: 0.5mk/kg to 2mg/kg QD AND Tacrolimus Dosing: 0.05 mg/kg BID

Primary Outcome Measure

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

Locations (9)

FacilityCityStateZIPSite coordinators
University of California at San FranciscoSan FranciscoCalifornia94143-
Northwestern University School of MedicineChicagoIllinois60611-
University of Kansas Medical CenterKansas CityKansas66160-
Mayo ClinicRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110-
Mount Sinai Medical CenterNew YorkNew York10029-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Tennessee- Methodist University HospitalMemphisTennessee38104-
Baylor University Medical CenterDallasTexas75246-

Find similar trials in San Francisco, CA

By research site
University of California at San Francisco· San Francisco, CANorthwestern University School of Medicine· Chicago, ILUniversity of Kansas Medical Center· Kansas City, KSMayo Clinic· Rochester, MNWashington University School of Medicine· St Louis, MOMount Sinai Medical Center· New York, NY

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