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

Eisai

Status: Completed

Conditions: Carcinoma, Hepatocellular; Liver Neoplasms

Treatments: Other: Non-interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT05225207

E7080-M082-509

Details and patient eligibility

About

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.

Enrollment: 658 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

658 participants in 1 patient group

All Participants

Description:

Participants with uHCC who are prescribed with Lenvima within the scope of the approved label for Korea under the medical judgment of the investigator will be enrolled and observed for up to 12 months.

Treatment:

Other: Non-interventional