Clinical trial · Observational
A Study of Overall Survival in Participants With Unresectable Hepatocellular Carcinoma
Specific Use Results Survey of LENVIMA 4 mg Capsules -Observational Study of Overall Survival in Patients With Unresectable Hepatocellular Carcinoma (Study LEN03T)
NCT04008082CI-TRIAL-00056947completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasms, Glandular and Epithelial | Neoplasm | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Lenvatinib
- description
- 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.
- interventionNames
- Drug: Lenvatinib
Primary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- From date of study drug administration until date of death from any cause (approximately 2.8 years)
- description
- OS is calculated as the period from the day of starting administration to the day of death from any cause.
- measure
- Presence or absence of factors with a possible influence on OS
- timeFrame
- From date of study drug administration until date of death from any cause (approximately 2.8 years)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDFuruse 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. PMID 39941845