Trial Condition(s):

Hepatocellular carcinoma

Sorafenib in Hepatocellular Carcinoma clinical practice in Italy (STELLA)

Bayer Identifier:

16028

ClinicalTrials.gov Identifier:

NCT01539681

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

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
234
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Italy

Status
Completed

Trial Design