Trial Condition(s):

Carcinoma, Hepatocellular

Sorafenib concomitantly used with TACE (Transarterial Chemoembolization) in uHCC (unresectable hepatocellular carcinoma) patients in China (SUCCESS)

Bayer Identifier:

16608

ClinicalTrials.gov Identifier:

NCT01839630

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
302
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, China

Status
Completed
 

Trial Design