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| ID | Type | Description | Link |
|---|---|---|---|
| LEN03T | Other Identifier | EISAI |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib capsule. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | 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 | 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) |
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Inclusion Criteria:
- All participants enrolled in the study E7080-M081-504 with informed consent to participate in this study.
Exclusion Criteria:
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Participants with unresectable hepatocellular carcinoma will be observed for specific use results survey of lenvima 4 mg capsules.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisai Trial Site #1 | Osaka | Japan | ||||
| Eisai Trial Site #2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39941845 | Derived | Furuse J, Izumi N, Motomura K, Inaba Y, Katamura Y, Kondo Y, Yabushita K, Matsuoka T, Motoyoshi K, Kudo M. Long-Term Survival of Patients with Unresectable Hepatocellular Carcinoma Treated with Lenvatinib in Real-World Clinical Practice. Cancers (Basel). 2025 Feb 1;17(3):479. doi: 10.3390/cancers17030479. |
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Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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| Tokyo |
| Japan |
| D009371 |
| Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |