Sorafenib Concomitantly Used With TACE (Transarterial Chemoembolization) in uHCC (Unresectable Hepatocellular Carcinoma) Patients in China

Study Overview
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Brief Summary
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This study is to obtain the characteristics and treatment pattern of the unresectable HCC patients who are candidates for systemic therapy and in whom a decision to treat with sorafenib from early stage of TACE treatment course (concomitantly use no later than the 3rd TACE procedure) has been made under real-life practice conditions.this study will also conclude the safety and effectiveness of combination in uHCC patients.

Official Title
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Study on Transarterial Chemoembolization Combined With Sorafenib in Chinese Patients With Unresectable Hepatocellular Carcinoma (SUCCESS)

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: Patients with histologically/ cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made. Radiographic diagnosis 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 receive the first dose of sorafenib no later than 1 week (<=7days) after the 3rd TACE procedure Patients did not receive other prior systemic treatment by using target therapy Patients must sign the informed consent form; Patients must have a life expectancy of at least 3 months; The physician must be willing to complete and submit all CRFs; The physician must be willing to submit to a site audit with verification of source documents and validation of data reported; Exclusion Criteria: The first dose of sorafenib 7 days after the 3nd TACE procedure Exclusion criteria must follow the approved local product information
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>* sorafenib treatment (including dose, duration, modification) and TACE procedure are decided by the investigator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summarized patient characteristics | Patient characteristics are hepatic virus infection status, surgery history, tumor size, number of tumor, macroscopic vascular invasion (MVI), extra-hepatic spread (EHS), cirrhosis, ECOG score, Child-Pugh score, BCLC stage, etc. | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolorability |  | up to 3 years | 
| overall survival (OS) by the mRECIST (Modified Response Evaluation Criteria in Solid Tumor) Criteria for treatment of uHCC patients |  | up to 3 years | 
| progression-free survival (PFS) by the mRECIST for treatment of uHCC patients |  | up to 3 years | 
| time to progression (TTP) by the mRECIST for treatment of uHCC patients |  | up to 3 years | 
| response rate (RR) by the mRECIST for treatment of uHCC patients |  | up to 3 years | 
| Clinical control Rate (DCR) by the mRECIST for treatment of uHCC patients |  | up to 3 years | 
| Clinical benefit rate (CBR) by the mRECIST for treatment of uHCC patients |  | up to 3 years | 
| Treatment pattern of Sorafenib | Treatment pattern included: Duration and dosage of Sorafenib treatment; reason for Sorafenib dosage modification/discontinuation; anticancer combination therapy; treatment after radiographic relapse; comorbidities and their impact on disease outcome. | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sorafenib, Hepatocellular cancer, TACE combination, Treatment pattern, Safety, Effectiveness