Carcinoma, Carcinoma, Hepatocellular, Neoplasms, Neoplasms, Glandular and Epithelial
Conditions
Keywords
Hepatocellular Carcinoma, Lenvatinib Mesilate, Lenvima, LEN03T
Brief summary
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.
Interventions
DRUGLenvatinib
Lenvatinib capsule.
Sponsors
Eisai Co., Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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who do not have unresectable hepatocellular carcinoma * Participants who have not given informed consent or have withdrawn consent to participation * Participants with a history of hypersensitivity to any ingredient of lenvima * Pregnant or possibly pregnant women * Participants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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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. |
| Presence or absence of factors with a possible influence on OS | 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. |
Countries
Japan
Outcome results
None listed