Status:
COMPLETED
Sorafenib Concomitantly Used With TACE (Transarterial Chemoembolization) in uHCC (Unresectable Hepatocellular Carcinoma) Patients in China
Lead Sponsor:
Bayer
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
Brief Summary
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 sta...
Eligibility Criteria
Inclusion
- 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
- The first dose of sorafenib 7 days after the 3nd TACE procedure
- Exclusion criteria must follow the approved local product information
Key Trial Info
Start Date :
May 30 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 29 2016
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT01839630
Start Date
May 30 2013
End Date
December 29 2016
Last Update
December 20 2017
Active Locations (1)
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1
Multiple Locations, China