NCT04297254

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Eisai Pharmaceuticals India Pvt. Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Lenvatinib	Lenvatinib capsules.

Timeline

• Start date: 2021-02-04
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2020-03-05
• Last updated: 2023-11-15

Locations

10 sites across 1 country: India