A Study to Assess the Safety and Efficacy of Lenvatinib as First-line Treatment in Participants With Unresectable HCC

Carcinoma, Hepatocellular Clinical Trial

Official title: A Prospective, Multicenter, Post-marketing Phase IV Study to Assess the Safety and Efficacy of Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma (HCC)

Status Completed

Clinical Trial Summary

The primary objective of this study is to evaluate the safety of lenvatinib in HCC.

Clinical Trial Description

This is a prospective, multi-center, open-label, single-arm, non-comparative, post-marketing phase IV study. This study will enroll 50 participants with unresectable HCC. Participants will receive lenvatinib for 24 weeks or until disease progression, death, intolerable or unacceptable toxicity, or withdrawal of consent, whichever occurs earlier. All participants will be followed up for an end-of-study (EOS) visit at 4 weeks after the completion of 24 weeks of treatment or after last treatment visit if earlier, as applicable that is end-of-treatment (EOT).

Participants who completed 24 weeks of therapy and continue to show clinical benefit will be able to continue to receive lenvatinib (beyond week 24 as necessary) as per Investigator's discretion and based on radiological response. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

• NCT number: NCT04297254
• Study type: Interventional
• Source: Eisai Inc.
• Status: Completed
• Phase: Phase 4
• Start date: February 4, 2021
• Completion date: July 31, 2023