Special Drug Use Investigation of Nexavar (Unresectable Hepatocellular Carcinoma)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 1,637
- Primary Endpoint
- Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who received Nexavar for unresectable hepatocellular carcinoma
Exclusion Criteria
- •Patients who are contraindicated based on the product label
Arms & Interventions
Group 1
Intervention: Sorafenib (Nexavar, BAY43-9006) (Drug)
Outcomes
Primary Outcomes
Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
Time Frame: After Nexavar administration, up to 1 year
Secondary Outcomes
- Demography(Baseline)
- Effectiveness evaluation assessment [overall survival, complete response rate, partial response rate, stable disease rate] by the Response Evaluation Criteria in Solid Tumor (RECIST)(After Nexavar administration, up to 1 year)
- Effectiveness evaluation assessment [time to progression, response rate, stable disease rate, progression rate] by investigator-determined overall best response(After Nexavar administration, up to 1 year)
- The status of therapy with Nexavar [duration of treatment, daily dose] in a various settings according to baseline data [such as demographic data, Child-Pugh status, ECOG-PS](After Nexavar administration, up to 1 year)