Overview

This trial is active, not recruiting.

Condition carcinoma, hepatocellular
Treatment sorafenib (nexavar, bay43-9006)
Sponsor Bayer
Start date May 2013
End date August 2016
Trial size 300 participants
Trial identifier NCT01839630, 16608, NX1216CN

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
sorafenib (nexavar, bay43-9006)
sorafenib treatment (including dose, duration, modification) and TACE procedure are decided by the investigator

Primary Outcomes

Measure
Summarized patient characteristics
time frame: up to 3 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Study of Unresectable HCC Treated Concomitantly With TACE and Sorafenib in Chinese Patients
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Bayer.