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

• Status: Completed
• Trial end date: 2016-12-29
• Target enrollment: 0
• Participant gender: All

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 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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Niacinamide; Sorafenib

Criteria

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