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Neoadjuvant Combination Therapy of Lenvatinib and TACE for Transplant-Eligible Large Hepatocellular Carcinoma Patients

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Jun 20, 2022 to Aug 20, 2022 Trial status changed: Enrolling by Invitation → Completed · Final enrollment: 5 participants (planned 50) · Primary completion date changed from estimate of Jun 30, 2026 to Sep 30, 2025 · 4 more Show 7 more changesShow less
    • Trial status changed: Enrolling by Invitation → Completed
    • Final enrollment: 5 participants (planned 50)
    • Primary completion date changed from estimate of Jun 30, 2026 to Sep 30, 2025
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Study description revised
    • Publications: details revised at 18 of 20 entries
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation Start date changed from estimate of Dec 30, 2021 to Jun 20, 2022 · Primary completion date: Sep 30, 2026 to Jun 30, 2026 · Completion date: Mar 30, 2027 to Dec 30, 2027v2 Show 3 more changesShow less
    • Start date changed from estimate of Dec 30, 2021 to Jun 20, 2022
    • Primary completion date: Sep 30, 2026 to Jun 30, 2026
    • Completion date: Mar 30, 2027 to Dec 30, 2027
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 will examine the effects of a six-month regimen of neoadjuvant lenvatinib in combination with transcatheter arterial chemoembolization (TACE) prior to liver transplantation in patients with hepatocellular carcinoma (HCC) beyond Milan Criteria. Clinical, outcomes, and exploratory data will be compared to a matched, retrospective cohort.
Trial Details
NCT Number NCT05171335
Lead Sponsor The Methodist Hospital Research Institute
Collaborators: Eisai Inc.
Conditions Hepatocellular Carcinoma
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov