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Real-World Lenvatinib Sequencing in Unresectable Hepatocellular Carcinoma (uHCC)

StatusActive, Not Recruiting
PhaseNot specified
SponsorEisai Inc.
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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This observational study will use existing real-world data from routine clinical care to describe patients with uHCC who received lenvatinib. The study will include two groups: patients who started lenvatinib as first-line (1L) treatment and patients who started lenvatinib as second-line (2L) treatment after prior 1L immunotherapy was stopped because the cancer progressed or because of toxicity. All study information will be collected retrospectively from existing patient records. Patients will be followed from the start of lenvatinib until death or their last documented follow-up before data extraction. The primary objectives of this study are: * To retrospectively evaluate the effectiveness of 1L lenvatinib in a real-world setting as measured by overall survival (OS) * To retrospectively evaluate the effectiveness of 2L lenvatinib as measured by OS after progression on or discontinuation of prior 1L immunotherapy * 1L immunotherapies to be considered include atezolizumab plus bevacizumab (Atezo/Bev) or durvalumab plus tremelimumab (Durva/Treme) combination therapies, based on preferred regimens listed by National Comprehensive Cancer Network (NCCN) 2025 guidelines
Trial Details
NCT Number NCT07849660
Lead Sponsor Eisai Inc.
Conditions Carcinoma, Hepatocellular
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov