Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib (GIDEON)

Bayer

Status: Completed

Conditions: Carcinoma, Hepatocellular

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

Study type: Observational

Funder types: Industry

Identifiers

NCT00812175

13414

NX0802 (Other Identifier)

Details and patient eligibility

About

In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.

Enrollment: 3,371 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients with histologically/cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with Nexavar has been made. Radiographic diagnosis HCC NIS, needs typical findings of HCC by radiographic method i.e. on multi-dimensional, dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP), or MRI.
• Patients must have signed an informed consent form
• Patients must have a life expectancy of at least 8 weeks

Exclusion criteria

• Exclusion criteria must follow the approved local product information

Trial design

3,371 participants in 1 patient group

Group 1

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)