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

NCT ID: NCT05225207

Last Updated: 2023-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

658 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-28

Study Completion Date

2022-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Neoplasms Carcinoma, Hepatocellular

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All Participants

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.

Non-interventional

Intervention Type OTHER

No intervention will be administered.

Interventions

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Non-interventional

No intervention will be administered.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Korea Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site #32

Cheonan, Chungcheongnam-do, South Korea

Site Status

Site #35

Bucheon-si, Gyeonggi-do, South Korea

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Site #38

Bucheon-si, Gyeonggi-do, South Korea

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Site #06

Goyang-si, Gyeonggi-do, South Korea

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Site #03

Seongnam-si, Gyeonggi-do, South Korea

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Site #13

Suwon, Gyeonggi-do, South Korea

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Site #27

Suwon, Gyeonggi-do, South Korea

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Site #15

Uijeongbu-si, Gyeonggi-do, South Korea

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Site #37

Changwon, Gyeongsangnam-do, South Korea

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Site #28

Yangsan, Gyeongsangnam-do, South Korea

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Site #29

Yangsan, Gyeongsangnam-do, South Korea

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Site #31

Busan, , South Korea

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Site #39

Busan, , South Korea

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Site #40

Busan, , South Korea

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Site #17

Daegu, , South Korea

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Site #18

Daegu, , South Korea

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Site #26

Daegu, , South Korea

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Site #30

Daegu, , South Korea

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Site #41

Daegu, , South Korea

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Site #19

Daejeon, , South Korea

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Site #20

Daejeon, , South Korea

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Site #24

Daejeon, , South Korea

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Site #34

Daejeon, , South Korea

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Site #21

Incheon, , South Korea

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Site #33

Incheon, , South Korea

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Site #36

Incheon, , South Korea

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Site #01

Seoul, , South Korea

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Site #02

Seoul, , South Korea

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Site #04

Seoul, , South Korea

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Site #07

Seoul, , South Korea

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Site #08

Seoul, , South Korea

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Site #09

Seoul, , South Korea

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Site #10

Seoul, , South Korea

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Site #12

Seoul, , South Korea

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Site #16

Seoul, , South Korea

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Site #22

Seoul, , South Korea

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Site #23

Seoul, , South Korea

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Site #25

Seoul, , South Korea

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Site #42

Seoul, , South Korea

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Site #43

Seoul, , South Korea

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Site #44

Seoul, , South Korea

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Site #11

Ulsan, , South Korea

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Countries

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South Korea

References

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Kang W, Kim YJ, Kim SU, Seo YS, Kim JW, Kim JH, Park SY, Baek YH, Kim KM, Lee HL, Yoon KT, Kim H, Cheong JY, Hwang JS, Kim JH, Kim KM, Sung PS, Kim J, Kim DY. Real-world safety and effectiveness of lenvatinib in unresectable hepatocellular carcinoma in Korea: post-marketing study. Future Oncol. 2024;20(37):2949-2959. doi: 10.1080/14796694.2024.2397328. Epub 2024 Sep 25.

Reference Type DERIVED
PMID: 39320906 (View on PubMed)

Other Identifiers

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E7080-M082-509

Identifier Type: -

Identifier Source: org_study_id

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