A Study of Overall Survival in Participants With Unresectable Hepatocellular Carcinoma

Neoplasms Clinical Trial

Official title:

Specific Use Results Survey of LENVIMA 4 mg Capsules -Observational Study of Overall Survival in Patients With Unresectable Hepatocellular Carcinoma (Study LEN03T)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008082
• Other study ID #: E7080-M081-510
• Secondary ID: LEN03T
• Status: Completed
• Start date: May 14, 2019
• Est. completion date: January 28, 2022

Study information

• Verified date: June 2021
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: January 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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• Participants who have not given informed consent or have withdrawn consent to participation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).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Neoplasms
• Neoplasms, Glandular and Epithelial

Intervention

Drug:
• Lenvatinib
Lenvatinib capsule.

Locations

Country	Name	City	State
Japan	Eisai Trial Site #1	Osaka
Japan	Eisai Trial Site #2	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS is calculated as the period from the day of starting administration to the day of death from any cause.	From date of study drug administration until date of death from any cause (approximately 2.8 years)
Primary	Presence or absence of factors with a possible influence on OS	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.	From date of study drug administration until date of death from any cause (approximately 2.8 years)