Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy (STELLA)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Sorafenib Treatment Modalities for HEpatoceLLular Carcinoma Patients in ItAly|
- Efficacy (analyzed by overall survival rate) of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma. [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
- Adverse event collection of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma. [ Time Frame: every 4 months on average within approx. 2 years ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
- Time to Progression [ Time Frame: every 4 months on average within approx. 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Drug: Sorafenib (Nexavar, BAY43-9006)
Subjects should be treated with sorafenib in compliance with the recommendations written in the local product information.However, the decision on the duration and dose of treatment is at the discretion of the prescribing physician.