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

Bayer

Status: Completed

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Sorafenib (Nexavar, BAY43-9006)

Study type: Observational

Funder types: Industry

Identifiers

NCT01839630

NX1216CN (Other Identifier)

16608

Details and patient eligibility

About

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.

Enrollment: 302 patients

Sex: All

Volunteers: No Healthy Volunteers

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 design

302 participants in 1 patient group

Group 1

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)