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

Sponsor

Eisai Korea Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05225207

Collaborator

(none)

600

Enrollment

Locations

42.1

Anticipated Duration (Months)

14.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Neoplasms Carcinoma, Hepatocellular	Other: Non-interventional

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 28, 2019

Actual Primary Completion Date :

Jan 31, 2022

Anticipated Study Completion Date :

Nov 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Non-interventional No intervention will be administered.

Arm

Intervention/Treatment

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.

Other: Non-interventional

No intervention will be administered.

Outcome Measures

Primary Outcome Measures

Number of Participants With Serious Adverse Events (SAEs) [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.
Number of Participants With Serious Adverse Drug Reactions (ADRs) [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.
Number of Participants With Unexpected AEs [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.
Number of Participants With Unexpected ADRs [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.
Number of Participants With Known ADRs [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.
Number of Participants With Non-serious ADRs [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 Outcome Measures

Percentage of Participants With Overall Response [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Site #32	Cheonan	Chungcheongnam-do	Korea, Republic of
2	Site #35	Bucheon	Gyeonggi-do	Korea, Republic of
3	Site #38	Bucheon	Gyeonggi-do	Korea, Republic of
4	Site #06	Goyang	Gyeonggi-do	Korea, Republic of
5	Site #03	Seongnam	Gyeonggi-do	Korea, Republic of
6	Site #13	Suwon	Gyeonggi-do	Korea, Republic of
7	Site #27	Suwon	Gyeonggi-do	Korea, Republic of
8	Site #15	Uijeongbu	Gyeonggi-do	Korea, Republic of
9	Site #37	Changwon	Gyeongsangnam-do	Korea, Republic of
10	Site #28	Yangsan	Gyeongsangnam-do	Korea, Republic of
11	Site #29	Yangsan	Gyeongsangnam-do	Korea, Republic of
12	Site #31	Busan		Korea, Republic of
13	Site #39	Busan		Korea, Republic of
14	Site #40	Busan		Korea, Republic of
15	Site #17	Daegu		Korea, Republic of
16	Site #18	Daegu		Korea, Republic of
17	Site #26	Daegu		Korea, Republic of
18	Site #30	Daegu		Korea, Republic of
19	Site #41	Daegu		Korea, Republic of
20	Site #19	Daejeon		Korea, Republic of
21	Site #20	Daejeon		Korea, Republic of
22	Site #24	Daejeon		Korea, Republic of
23	Site #34	Daejeon		Korea, Republic of
24	Site #21	Incheon		Korea, Republic of
25	Site #33	Incheon		Korea, Republic of
26	Site #36	Incheon		Korea, Republic of
27	Site #01	Seoul		Korea, Republic of
28	Site #02	Seoul		Korea, Republic of
29	Site #04	Seoul		Korea, Republic of
30	Site #07	Seoul		Korea, Republic of
31	Site #08	Seoul		Korea, Republic of
32	Site #09	Seoul		Korea, Republic of
33	Site #10	Seoul		Korea, Republic of
34	Site #12	Seoul		Korea, Republic of
35	Site #16	Seoul		Korea, Republic of
36	Site #22	Seoul		Korea, Republic of
37	Site #23	Seoul		Korea, Republic of
38	Site #25	Seoul		Korea, Republic of
39	Site #42	Seoul		Korea, Republic of
40	Site #43	Seoul		Korea, Republic of
41	Site #44	Seoul		Korea, Republic of
42	Site #11	Ulsan		Korea, Republic of

Sponsors and Collaborators

Eisai Korea Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eisai Korea Inc.

ClinicalTrials.gov Identifier:

NCT05225207

Other Study ID Numbers:

E7080-M082-509

First Posted:

Feb 4, 2022

Last Update Posted:

Mar 15, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Eisai Korea Inc.

Lenvatinib

Lenvima

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Study Results

No Results Posted as of Mar 15, 2022