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

Completed

• Conditions: Carcinoma, Hepatocellular
• Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)

• Registration Number: NCT01839630
• Lead Sponsor: Bayer

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-23
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-25
• Study Start: 2013-05-30
• Primary Completion: 2016-08-06
• Study Completion: 2016-12-29
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

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;

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Exclusion Criteria

• The first dose of sorafenib 7 days after the 3nd TACE procedure
• Exclusion criteria must follow the approved local product information

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Sorafenib (Nexavar, BAY43-9006)	-

Primary Outcome Measures

Name	Time	Method
Summarized patient characteristics	up to 3 years	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.

Secondary Outcome Measures

Name	Time	Method
progression-free survival (PFS) 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
time to progression (TTP) 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
Treatment pattern of Sorafenib	up to 3 years	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.
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
Clinical benefit rate (CBR) by the mRECIST for treatment of uHCC patients	up to 3 years