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

Carcinoma, Hepatocellular Clinical Trial

— SUCCESS  

Official title:

Study on Transarterial Chemoembolization Combined With Sorafenib in Chinese Patients With Unresectable Hepatocellular Carcinoma (SUCCESS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839630
• Other study ID #: 16608
• Secondary ID: NX1216CN
• Status: Completed
• Phase: N/A
• First received: November 23, 2012
• Last updated: December 19, 2017
• Start date: May 30, 2013
• Est. completion date: December 29, 2016

Study information

• Verified date: December 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: December 29, 2016
• Est. primary completion date: August 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
sorafenib treatment (including dose, duration, modification) and TACE procedure are decided by the investigator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summarized patient characteristics	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.	up to 3 years
Secondary	Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolorability		up to 3 years
Secondary	overall survival (OS) by the mRECIST (Modified Response Evaluation Criteria in Solid Tumor) Criteria for treatment of uHCC patients		up to 3 years
Secondary	progression-free survival (PFS) by the mRECIST for treatment of uHCC patients		up to 3 years
Secondary	time to progression (TTP) by the mRECIST for treatment of uHCC patients		up to 3 years
Secondary	response rate (RR) by the mRECIST for treatment of uHCC patients		up to 3 years
Secondary	Clinical control Rate (DCR) by the mRECIST for treatment of uHCC patients		up to 3 years
Secondary	Clinical benefit rate (CBR) by the mRECIST for treatment of uHCC patients		up to 3 years
Secondary	Treatment pattern of Sorafenib	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.	up to 3 years

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