Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy (STELLA)

Bayer

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Sorafenib (Nexavar, BAY43-9006)

Study type: Observational

Funder types: Industry

Identifiers

NCT01539681

16028

NX1110IT (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

234 participants in 1 patient group

Group 1

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)