A Study of Overall Survival in Participants With Unresectable Hepatocellular Carcinoma

Completed

• Conditions: Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Hepatocellular; Neoplasms
• Interventions: Drug: Lenvatinib

• Registration Number: NCT04008082
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The primary purpose of this study to continue follow-up of participants enrolled in the study E7080-M081-504 (NCT03663114) of lenvima capsules and to evaluate the overall survival of participants with hepatocellular carcinoma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-13
• Study Start: 2019-05-14
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-05
• Status Verified: 2021-06
• Primary Completion: 2022-01-28
• Study Completion: 2022-01-28
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

Inclusion Criteria

• All participants enrolled in the study E7080-M081-504 with informed consent to participate in this study.

Exclusion Criteria

• Participants who do not have unresectable hepatocellular carcinoma
• Participants who have not given informed consent or have withdrawn consent to participation
• Participants with a history of hypersensitivity to any ingredient of lenvima
• Pregnant or possibly pregnant women
• Participants previously treated with lenvima (excluding those previously enrolled in the Study E7080-M081-504 [NCT03663114] at another clinical site).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lenvatinib	Lenvatinib	Lenvatinib capsules 12 milligram (mg) for participants with body weight greater than or equal to (\>=) 60 kilograms (kg) or 8 mg for participants with body weight less than (\<) 60 kg, orally, once daily as per routine clinical practice.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From date of study drug administration until date of death from any cause (approximately 2.8 years)	OS is calculated as the period from the day of starting administration to the day of death from any cause.
Presence or absence of factors with a possible influence on OS	From date of study drug administration until date of death from any cause (approximately 2.8 years)	Factor analysis is performed according to the category of participant background (aetiology of chronic liver disease, baseline alpha-fetoprotein concentration etc), lenvima administration status and treatment situation before and after administration of lenvima, and factors affecting OS are examined. Appropriate statistical methods (Cox regression analysis, etc.) will be used to examine the relationship of OS with various factors in order to identify the factors affecting survival.

Trial Locations

Locations (2)

Eisai Trial Site #2; 🇯🇵 Tokyo, Japan

Eisai Trial Site #1; 🇯🇵 Osaka, Japan