A Study of Overall Survival in Participants With Unresectable Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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.

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

Conditions
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Carcinoma, Hepatocellular, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms

Intervention / Treatment
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* Drug: Lenvatinib


Participation Criteria
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Eligibility Criteria
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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who do not have unresectable hepatocellular carcinoma Participants who have not given informed consent or have withdrawn consent to participation Participants with a history of hypersensitivity to any ingredient of lenvima Pregnant or possibly pregnant women Participants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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lenvatinib<br>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. | Drug: Lenvatinib<br>* Lenvatinib capsule.<br>* Other names: E7080;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, Lenvatinib Mesilate, Lenvima, LEN03T