Clinical trial · Observational
Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan
Special Drug Use Investigation of Nexavar (Unresectable Hepatocellular Carcinoma)
- 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)
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Nexavar for unresectable hepatocellular carcinoma (HCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 2 or 3 months (dependent on sites) for Child-Pugh A; for Child-Pugh B or C, the enrollment continues until agreement to stop with Pharmaceuticals Medical Devices Agency (PMDA). All patients who have received Nexavar will be recruited and followed one year since starting Nexavar administration.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- interventionNames
- Drug: Sorafenib (Nexavar, BAY43-9006)
Primary outcomes (1)
- measure
- Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
- timeFrame
- After Nexavar administration, up to 1 year
Secondary outcomes (4)
- measure
- Demography
- timeFrame
- Baseline
- measure
- Effectiveness evaluation assessment [overall survival, complete response rate, partial response rate, stable disease rate] by the Response Evaluation Criteria in Solid Tumor (RECIST)
- timeFrame
- After Nexavar administration, up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients who received Nexavar for unresectable hepatocellular carcinoma Exclusion Criteria: * Patients who are contraindicated based on the product label
References
Publications (1)
- DERIVEDKaneko S, Ikeda K, Matsuzaki Y, Furuse J, Minami H, Okayama Y, Sunaya T, Ito Y, Inuyama L, Okita K. Safety and effectiveness of sorafenib in Japanese patients with hepatocellular carcinoma in daily medical practice: interim analysis of a prospective postmarketing all-patient surveillance study. J Gastroenterol. 2016 Oct;51(10):1011-21. doi: 10.1007/s00535-016-1173-5. Epub 2016 Mar 1. PMID 26931117