A Study of Overall Survival in Participants With Unresectable Hepatocellular Carcinoma

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 28, 2022

Interventions

  • Drug: Lenvatinib
    • Lenvatinib capsule.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Overall Survival (OS)
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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who do not have unresectable hepatocellular carcinoma – Participants who have not given informed consent or have withdrawn consent to participation – Participants with a history of hypersensitivity to any ingredient of lenvima – Pregnant or possibly pregnant women – Participants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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eisai Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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