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Completed

NCT Number: NCT05225207

A Study of Lenvima (Lenvatinib) in Korean Unresectable Hepatocellular Carcinoma (uHCC) Participants

The purpose of this study is to describe the following safety and the efficacy of Lenvima for the first-line treatment indication of participants with uHHC in the post marketing setting: (1) Serious adverse events and serious adverse drug reactions (2) Unexpected adverse events and adverse drug reactions not reflected in the precautions for use (3) Known adverse drug reactions (4) Non-serious adverse drug reactions (5) Other safety and efficacy related information.

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Key information

Conditions

Liver Neoplasms Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases 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

Site #32, Cheonan, Chungcheongnam-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants over 18 years
  • Participants who are treated with lenvatinib according to the approved indication of uHCC as first-line therapy in Korea
  • Participants who have given their consent to study participation about the use of the personal data and medical data

Exclusion criteria

  • Participants who have hypersensitivity to active pharmaceutical ingredients or excipient of the study drug (lenvatinib)
  • Participants who are pregnant or breastfeeding.

Treatment and study plan

Non-Interventional

Other

No intervention will be administered.

Primary outcomes

  1. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: From first dose of study drug up to 12 months

    A SAE is defined as any untoward medical occurrence: resulting in death; life threatening requiring hospitalization or prolongation of hospitalization; resulting in persistent or significant disability or incapacity; resulting in birth defect or congenital anomaly or medically important due to other reasons than above mentioned criteria.

  2. Number of Participants With Serious Adverse Drug Reactions (ADRs)

    Time frame: From first dose of study drug up to 12 months

    Serious ADR is defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition.

  3. Number of Participants With Unexpected AEs

    Time frame: From first dose of study drug up to 12 months

    AE is defined as any untoward and unintended signs (example, anomalies in laboratory test results) or symptoms/diseases occurring during administration/use of drugs, etc., which do not necessarily have a causal relationship with the drug in question.

  4. Number of Participants With Unexpected ADRs

    Time frame: From first dose of study drug up to 12 months

    An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.

  5. Number of Participants With Known ADRs

    Time frame: From first dose of study drug up to 12 months

    An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.

  6. Number of Participants With Non-serious ADRs

    Time frame: From first dose of study drug up to 12 months

    An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. AEs with unknown causality to the drug among those voluntarily reported will be also considered ADRs.

Secondary outcomes

  1. Percentage of Participants With Overall Response

    Time frame: From first dose of study drug up to 12 months

    Overall response will include complete response (CR), and partial response (PR). The confirmation of overall response will be based on investigator's judgement.

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Official study title

A Study of Lenvatinib in Korean Unresectable Hepatocellular Carcinoma (uHCC) Patients as a Post-marketing Surveillance

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2022
Registry last updated
Jan 9, 2023

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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