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

Completed

• Conditions: Carcinoma, Hepatocellular
• Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)

• Registration Number: NCT00812175
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Study Start: 2009-01
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3371

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Sorafenib (Nexavar, BAY43-9006)	-

Primary Outcome Measures

Name	Time	Method
The safety of Nexavar in all patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions	at each follow-up visit, every 2-4 months on average

Secondary Outcome Measures

Name	Time	Method
Efficacy [overall survival (OS), progression-free survival (PFS), time to progression (TTP), response rate (RR), stable disease(SD) rate] by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria of Nexavar	at every visit, roughly every 2-4 months
The duration of therapy with Nexavar in a variety of settings according to patient characteristics and other variables	at every visit, roughly every 2-4 months
Reports of adverse events	at every visit, roughly every 2-4 months
To evaluate the methods of patient evaluation, diagnosis and follow up	at every visit, roughly every 2-4 months
To evaluate the co-morbidities in patients with unresectable HCC and their influence on treatment and outcome	at every visit, roughly every 2-4 months
To evaluate the practice patterns of the physicians involved in the care of patients with HCC under real-life conditions	at every visit, roughly every 2-4 months