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

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

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

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Drug: Sorafenib (Nexavar, BAY43-9006)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* Systemic oral therapy according to product information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Reports of adverse events |  | at every visit, roughly every 2-4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, HCC, Sorafenib