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ACTIVE NOT RECRUITING
NCT07849660

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

Sponsor: Eisai Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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