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Completed

NCT Number: NCT04008082

A Study of Overall Survival in Participants With Unresectable Hepatocellular Carcinoma

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eisai Trial Site #1, Osaka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Participants who have not given informed consent or have withdrawn consent to participation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

Treatment and study plan

Lenvatinib

Drug

Lenvatinib capsule.

Other names: Lenvima, E7080

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2019
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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