Liver NeoplasmsNCT05225207
A Study of Lenvima (Lenvatinib) in Korean Unresectable Hepatocellular Carcinoma (uHCC) Participants
An observational study of Liver Neoplasms and Carcinoma, Hepatocellular, run by Eisai Korea Inc. at 42 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms, Carcinoma, Hepatocellular
- What is being tested?
- Non-interventional
- How many people
- 658 participants
- Where
- 42 sitesSouth Korea
- Study dates
- 28 May 2019to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with uHHC administered with Lenvima within the scope of the approved label for Korea under the medical judgment of the investigator.
Who may be able to join
- 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
Who cannot join
- Participants who have hypersensitivity to active pharmaceutical ingredients or excipient of the study drug (lenvatinib)
- Participants who are pregnant or breastfeeding.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
South Korea42 sites
Site #35
Bucheon-si, Gyeonggi-do
Site #38
Bucheon-si, Gyeonggi-do
Site #31
Busan
Site #39
Busan
Site #40
Busan
Site #37
Changwon, Gyeongsangnam-do
Site #32
Cheonan, Chungcheongnam-do
Site #17
Daegu
Site #18
Daegu
Site #26
Daegu
Site #30
Daegu
Site #41
Daegu
Site #19
Daejeon
Site #20
Daejeon
Site #24
Daejeon
Site #34
Daejeon
Site #06
Goyang-si, Gyeonggi-do
Site #21
Incheon
Site #33
Incheon
Site #36
Incheon
Site #03
Seongnam-si, Gyeonggi-do
Site #01
Seoul
Site #02
Seoul
Site #04
Seoul
Site #07
Seoul
Site #08
Seoul
Site #09
Seoul
Site #10
Seoul
Site #12
Seoul
Site #16
Seoul
Site #22
Seoul
Site #23
Seoul
Site #25
Seoul
Site #42
Seoul
Site #43
Seoul
Site #44
Seoul
Site #13
Suwon, Gyeonggi-do
Site #27
Suwon, Gyeonggi-do
Site #15
Uijeongbu-si, Gyeonggi-do
Site #11
Ulsan
Site #28
Yangsan, Gyeongsangnam-do
Site #29
Yangsan, Gyeongsangnam-do
About this study
Official title: A Study of Lenvatinib in Korean Unresectable Hepatocellular Carcinoma (uHCC) Patients as a Post-marketing Surveillance
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.
- Conditions
- Liver Neoplasms, Carcinoma, Hepatocellular
- Being tested
- Non-interventional
- Keywords
- Lenvatinib, Lenvima
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
No intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Serious Adverse Events (SAEs)
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.
Measured: From first dose of study drug up to 12 months
Number of Participants With Serious Adverse Drug Reactions (ADRs)
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.
Measured: From first dose of study drug up to 12 months
Number of Participants With Unexpected AEs
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.
Measured: From first dose of study drug up to 12 months
Number of Participants With Unexpected ADRs
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.
Measured: From first dose of study drug up to 12 months
Number of Participants With Known ADRs
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.
Measured: From first dose of study drug up to 12 months
Number of Participants With Non-serious ADRs
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.
Measured: From first dose of study drug up to 12 months
Secondary outcomes (1)
Percentage of Participants With Overall Response
Overall response will include complete response (CR), and partial response (PR). The confirmation of overall response will be based on investigator's judgement.
Measured: From first dose of study drug up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start28 May 2019
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 658 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225207
- Sponsor's protocol ID
- E7080-M082-509
- Status last verified
- Jan 2022
- First submitted
- 26 Jan 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Publications
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.
PubMed 39320906
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Lenvatinib in Korean Unresectable Hepatocellular Carcinoma (uHCC) Patients as a Post-marketing Surveillance
- ClinicalTrials.gov ID
- NCT05225207
- Acronym / sponsor ID
- E7080-M082-509
- Conditions
- Liver Neoplasms, Carcinoma, Hepatocellular
- Keywords
- Lenvatinib, Lenvima
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 658 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 28 May 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: Non-interventionalParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with uHHC administered with Lenvima within the scope of the approved label for Korea under the medical judgment of the investigator.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Participants who have hypersensitivity to active pharmaceutical ingredients or excipient of the study drug (lenvatinib)
- Participants who are pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalNo intervention will be administered. | Other | All Participants |
Primary outcome
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.
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.
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.
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.
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.
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.
1 secondary outcome
Percentage of Participants With Overall Response
Time frame: From first dose of study drug up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Derived from this study: PubMed 39320906Kang 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.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Related trials for Liver Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Neoplasms and Carcinoma, Hepatocellular, run by Eisai Korea Inc. at 42 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Serious Adverse Events (SAEs) (time frame: From first dose of study drug up to 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05225207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.