Clinical trial · Observational
A Study of Lenvima (Lenvatinib) in Korean Unresectable Hepatocellular Carcinoma (uHCC) Participants
A Study of Lenvatinib in Korean Unresectable Hepatocellular Carcinoma (uHCC) Patients as a Post-marketing Surveillance
- 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 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
Conditions (2)
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, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-interventional | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All Participants
- description
- 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.
- interventionNames
- Other: Non-interventional
Primary outcomes (6)
- measure
- Number of Participants With Serious Adverse Events (SAEs)
- timeFrame
- From first dose of study drug up to 12 months
- description
- 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.
- measure
- Number of Participants With Serious Adverse Drug Reactions (ADRs)
- timeFrame
- From first dose of study drug up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants over 18 years 2. Participants who are treated with lenvatinib according to the approved indication of uHCC as first-line therapy in Korea 3. Participants who have given their consent to study participation about the use of the personal data and medical data Exclusion Criteria: 1. Participants who have hypersensitivity to active pharmaceutical ingredients or excipient of the study drug (lenvatinib) 2. Participants who are pregnant or breastfeeding.
References
Publications (1)
- DERIVEDKang 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. PMID 39320906