Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy
- Registration Number
- NCT01539681
- Lead Sponsor
- Bayer
- Brief Summary
Prospective, non-interventional, multi-center study. Patients affected by Hepatocellular Carcinoma (HCC) who are candidates for systemic therapy and in whom a decision to treat with sorafenib has been made. Aim of this non-interventional, post-marketing study is to evaluate the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with HCC under daily-life treatment conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
Inclusion Criteria
- Patients with histologically/cytologically confirmed HCC or radiographically diagnosed as per AASLD criteria, who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made
- Patients must have signed the informed consent form
- Patients must have a life expectancy of at least 8 weeks Inclusion criteria must follow the approved local product information.
Exclusion Criteria
- Prior treatment with sorafenib
- Concomitant participation in other clinical studies Exclusion criteria must follow the approved local product information.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Sorafenib (Nexavar, BAY43-9006) -
- Primary Outcome Measures
Name Time Method Efficacy (analyzed by overall survival rate) of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma. at 1 year
- Secondary Outcome Measures
Name Time Method Overall survival at 1 year Adverse event collection of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma. every 4 months on average within approx. 2 years Time to Progression every 4 months on average within approx. 2 years