Clinical trial NCT05225207: A Study of Lenvima (Lenvatinib) in Korean Unresectable Hepatocellular Carcinoma (uHCC) Participants
Official title: A Study of Lenvatinib in Korean Unresectable Hepatocellular Carcinoma (uHCC) Patients as a Post-marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Neoplasms
Carcinoma, Hepatocellular
Keywords: Lenvatinib
Lenvima
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-04
Enrollment: 658
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with uHHC administered with Lenvima within the scope of the approved label for Korea under the medical judgment of the investigator.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From first dose of study drug up to 12 months
measure: Number of Participants With Serious Adverse Drug Reactions (ADRs)
timeFrame: From first dose of study drug up to 12 months
measure: Number of Participants With Unexpected AEs
timeFrame: From first dose of study drug up to 12 months
measure: Number of Participants With Unexpected ADRs
timeFrame: From first dose of study drug up to 12 months
measure: Number of Participants With Known ADRs
timeFrame: From first dose of study drug up to 12 months
measure: Number of Participants With Non-serious ADRs
timeFrame: From first dose of study drug up to 12 months
Secondary outcomes:
measure: Percentage of Participants With Overall Response
timeFrame: From first dose of study drug up to 12 months
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Site #32
state: Chungcheongnam-do
city: Bucheon
country: Korea, Republic of
facility: Site #35
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Site #38
state: Gyeonggi-do
city: Goyang
country: Korea, Republic of
facility: Site #06
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Site #03
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Site #13
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Site #27
state: Gyeonggi-do
city: Uijeongbu
country: Korea, Republic of
facility: Site #15
state: Gyeonggi-do
city: Changwon
country: Korea, Republic of
facility: Site #37
state: Gyeongsangnam-do
city: Yangsan
country: Korea, Republic of
facility: Site #28
state: Gyeongsangnam-do
city: Yangsan
country: Korea, Republic of
facility: Site #29
state: Gyeongsangnam-do
city: Busan
country: Korea, Republic of
facility: Site #31
city: Busan
country: Korea, Republic of
facility: Site #39
city: Busan
country: Korea, Republic of
facility: Site #40
city: Daegu
country: Korea, Republic of
facility: Site #17
city: Daegu
country: Korea, Republic of
facility: Site #18
city: Daegu
country: Korea, Republic of
facility: Site #26
city: Daegu
country: Korea, Republic of
facility: Site #30
city: Daegu
country: Korea, Republic of
facility: Site #41
city: Daejeon
country: Korea, Republic of
facility: Site #19
city: Daejeon
country: Korea, Republic of
facility: Site #20
city: Daejeon
country: Korea, Republic of
facility: Site #24
city: Daejeon
country: Korea, Republic of
facility: Site #34
city: Incheon
country: Korea, Republic of
facility: Site #21
city: Incheon
country: Korea, Republic of
facility: Site #33
city: Incheon
country: Korea, Republic of
facility: Site #36
city: Seoul
country: Korea, Republic of
facility: Site #01
city: Seoul
country: Korea, Republic of
facility: Site #02
city: Seoul
country: Korea, Republic of
facility: Site #04
city: Seoul
country: Korea, Republic of
facility: Site #07
city: Seoul
country: Korea, Republic of
facility: Site #08
city: Seoul
country: Korea, Republic of
facility: Site #09
city: Seoul
country: Korea, Republic of
facility: Site #10
city: Seoul
country: Korea, Republic of
facility: Site #12
city: Seoul
country: Korea, Republic of
facility: Site #16
city: Seoul
country: Korea, Republic of
facility: Site #22
city: Seoul
country: Korea, Republic of
facility: Site #23
city: Seoul
country: Korea, Republic of
facility: Site #25
city: Seoul
country: Korea, Republic of
facility: Site #42
city: Seoul
country: Korea, Republic of
facility: Site #43
city: Seoul
country: Korea, Republic of
facility: Site #44
city: Ulsan
country: Korea, Republic of
facility: Site #11
Study officials:
References: