Trial Condition(s):
Hepatocellular carcinoma
Sorafenib in Hepatocellular Carcinoma clinical practice in Italy (STELLA)
Bayer Identifier:
16028
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Italy | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Sorafenib Treatment modalities for HEpatoceLLular Carcinoma patients in ItAly
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Efficacy (analyzed by overall survival rate) of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.Timeframe: at 1 year
Secondary Outcome
- Adverse event collection of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.Timeframe: every 4 months on average within approx. 2 years
- Overall survivalTimeframe: at 1 year
- Time to ProgressionTimeframe: every 4 months on average within approx. 2 years
Additional Information
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