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

StatusEnrolling by Invitation
PhasePhase 4
Started
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Record History

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  1. Trial status: Active, Not Recruiting to Enrolling by Invitation
    • Primary and study completion dates: Jun 2024 to Mar 2027
    v10
  2. Primary and study completion dates: Jan 2023 to Jun 2024v9
  3. Primary and study completion dates: Jan 2021 to Jan 2023v8
  4. Primary and study completion dates: Aug 2019 to Jan 2021
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 10 to 9
    v7
  5. Primary and study completion dates: Oct 2018 to Aug 2019
    • Site contacts updated at 1 of 10 sites
    • Eligibility criteria expanded, about 2 words
    • Study description shortened, about 3 words
    v6
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  1. Interventions: CellCept (Drug), Everolimus (Drug), Myfortic (Drug), Tacrolimus (Drug) to CellCept (Drug), Everolimus (Drug), Imuran (Drug), Myfortic (Drug), Tacrolimus (Drug)v5 Show 4 more changesShow less
    • Eligibility criteria shortened, about 75 words
    • Secondary endpoints: 7 to 10
    • Site contacts updated at 2 of 10 sites
    • Study description expanded, about 5 words
  2. Study sites: 1 to 10
    • Primary and study completion dates: Jun 2018 to Oct 2018
    • Study description revised
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Eligibility criteria expanded, about 5 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02081755
Lead Sponsor Baylor Research Institute
Conditions
(from sponsor)		 Carcinoma, Hepatocellular
Related terms Carcinoma, Hepatocellular
Enrollment 336 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov