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Real-World Lenvatinib Sequencing in Unresectable Hepatocellular Carcinoma (uHCC)
Sponsor: Eisai Inc.
Summary
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
Official title: Understanding Real-World Sequencing Outcomes in Unresectable Hepatocellular Carcinoma (uHCC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
170
Start Date
2025-11-17
Completion Date
2026-12-15
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
Lenvatinib
12 milligram (mg) based on the participant's body weight greater than or equal to (≥) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (\<) 60 kg at baseline, orally, once daily (QD)
Locations (1)
Eisai Trial Site #1
Nutley, New Jersey, United States