Trial Information
Sorafenib Treatment Modalities for HEpatoceLLular Carcinoma Patients in ItAly
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Efficacy (analyzed by overall survival rate) of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.
Outcome Time Frame:
at 1 year
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Italy: Italian Medicines Agency (AIFA)
Study ID:
16028
NCT ID:
NCT01539681
Start Date:
February 2012
Completion Date:
March 2015
Related Keywords:
- Hepatocellular Carcinoma
- Hepatocellular Carcinoma
- Cancer, Liver
- Sorafenib
- Nexavar
- Carcinoma
- Carcinoma, Hepatocellular