- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04008082
A Study of Overall Survival in Participants With Unresectable Hepatocellular Carcinoma
March 7, 2022 updated by: Eisai Co., Ltd.
Specific Use Results Survey of LENVIMA 4 mg Capsules -Observational Study of Overall Survival in Patients With Unresectable Hepatocellular Carcinoma (Study LEN03T)
The primary purpose of this study to continue follow-up of participants enrolled in the study E7080-M081-504 (NCT03663114) of lenvima capsules and to evaluate the overall survival of participants with hepatocellular carcinoma.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
412
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Osaka, Japan
- Eisai Trial Site #1
-
Tokyo, Japan
- Eisai Trial Site #2
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants with unresectable hepatocellular carcinoma will be observed for specific use results survey of lenvima 4 mg capsules.
Description
Inclusion Criteria:
- All participants enrolled in the study E7080-M081-504 with informed consent to participate in this study.
Exclusion Criteria:
- Participants who do not have unresectable hepatocellular carcinoma
- Participants who have not given informed consent or have withdrawn consent to participation
- Participants with a history of hypersensitivity to any ingredient of lenvima
- Pregnant or possibly pregnant women
- Participants previously treated with lenvima (excluding those previously enrolled in the Study E7080-M081-504 [NCT03663114] at another clinical site).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lenvatinib
Lenvatinib capsules 12 milligram (mg) for participants with body weight greater than or equal to (>=) 60 kilograms (kg) or 8 mg for participants with body weight less than (<) 60 kg, orally, once daily as per routine clinical practice.
|
Lenvatinib capsule.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: From date of study drug administration until date of death from any cause (approximately 2.8 years)
|
OS is calculated as the period from the day of starting administration to the day of death from any cause.
|
From date of study drug administration until date of death from any cause (approximately 2.8 years)
|
Presence or absence of factors with a possible influence on OS
Time Frame: From date of study drug administration until date of death from any cause (approximately 2.8 years)
|
Factor analysis is performed according to the category of participant background (aetiology of chronic liver disease, baseline alpha-fetoprotein concentration etc), lenvima administration status and treatment situation before and after administration of lenvima, and factors affecting OS are examined.
Appropriate statistical methods (Cox regression analysis, etc.) will be used to examine the relationship of OS with various factors in order to identify the factors affecting survival.
|
From date of study drug administration until date of death from any cause (approximately 2.8 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 14, 2019
Primary Completion (Actual)
January 28, 2022
Study Completion (Actual)
January 28, 2022
Study Registration Dates
First Submitted
May 13, 2019
First Submitted That Met QC Criteria
July 3, 2019
First Posted (Actual)
July 5, 2019
Study Record Updates
Last Update Posted (Actual)
March 8, 2022
Last Update Submitted That Met QC Criteria
March 7, 2022
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Adenocarcinoma
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Neoplasms, Glandular and Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Lenvatinib
Other Study ID Numbers
- E7080-M081-510
- LEN03T (Other Identifier: EISAI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neoplasms
-
GlaxoSmithKlineCompleted
-
Amphia HospitalRecruitingColonic Neoplasms MalignantNetherlands
-
Marquette General Health SystemUpper Michigan Brain Tumor CenterWithdrawnGlioma | MeningiomaUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompletedBrain Stem Neoplasms, Primary | Neoplasms, Brain StemUnited States
-
GlaxoSmithKlineRecruitingNeoplasms, RectalUnited States, France, Italy, Japan, Spain, United Kingdom, Germany, Korea, Republic of, Canada, Netherlands
-
Russian Society of Colorectal SurgeonsRecruitingNeoplasms,ColorectalRussian Federation
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
-
Novartis PharmaceuticalsBayerCompletedColorectal Neoplasms | Rectal Neoplasms | Colonic NeoplasmsUnited States, Germany, Belgium, Canada, Spain, United Kingdom, Taiwan, France, Switzerland, Sweden, Portugal, New Zealand, Italy, Slovakia, Australia, Austria, Brazil, Hong Kong
-
University of Michigan Rogel Cancer CenterNational Cancer Institute (NCI); Department of Health and Human Services; Early... and other collaboratorsRecruitingColonic NeoplasmsUnited States, Canada, Australia
Clinical Trials on Lenvatinib
-
Memorial Sloan Kettering Cancer CenterCompletedHead and Neck Cancer | Head and Neck Squamous Cell Carcinoma | Head and Neck Carcinoma | Cutaneous Squamous Cell CarcinomaUnited States
-
Regina Elena Cancer InstituteUniversity of Pisa; University of Roma La Sapienza; University of Turin, Italy; Istituto Oncologico Veneto IRCCS and other collaboratorsRecruitingDifferentiated Thyroid Cancer | GenderItaly
-
Shanghai Junshi Bioscience Co., Ltd.Active, not recruitingAdvanced Hepatocellular Carcinoma (HCC)Italy, Poland, Singapore, United States, China, Ukraine
-
Shandong New Time Pharmaceutical Co., LTDRecruitingHepatocellular CarcinomaChina
-
Cancer Institute and Hospital, Chinese Academy...Active, not recruitingHepatocellular Carcinoma | Radiotherapy | LenvatinibChina
-
CStone PharmaceuticalsActive, not recruitingHepatocellular CarcinomaSpain, China, United States, Poland, Italy, Taiwan
-
Fudan UniversityActive, not recruitingHepatocellular CarcinomaChina
-
Eisai Inc.Merck Sharp & Dohme LLCCompletedSolid TumorsUnited States, China, Belgium, Australia, Italy, Korea, Republic of, Germany, Netherlands, Poland, Romania, Thailand
-
Eisai Inc.CompletedThyroid CancerUnited States, Australia, France, Poland, United Kingdom, Italy
-
Shanghai Zhongshan HospitalActive, not recruitingCholangiocarcinoma, IntrahepaticChina