Clinical trial NCT01839630: Sorafenib Concomitantly Used With TACE (Transarterial Chemoembolization) in uHCC (Unresectable Hepatocellular Carcinoma) Patients in China
Official title: Study on Transarterial Chemoembolization Combined With Sorafenib in Chinese Patients With Unresectable Hepatocellular Carcinoma (SUCCESS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Keywords: Sorafenib
Hepatocellular cancer
TACE combination
Treatment pattern
Safety
Effectiveness
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-04-25
Enrollment: 302
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unresectable HCC patients and be candidates for concomitantly systemic therapy with sorafenib + TACE. Considering the local practice and possible clinical benefits, sorafenib should not be initiated later than 7 days after the 3rd TACE course. No prior tartgeted therapy.

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.


Eligibility 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

Primary outcomes:
measure: Summarized patient characteristics
timeFrame: 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
timeFrame: up to 3 years
measure: overall survival (OS) by the mRECIST (Modified Response Evaluation Criteria in Solid Tumor) Criteria for treatment of uHCC patients
timeFrame: up to 3 years
measure: progression-free survival (PFS) by the mRECIST for treatment of uHCC patients
timeFrame: up to 3 years
measure: time to progression (TTP) by the mRECIST for treatment of uHCC patients
timeFrame: up to 3 years
measure: response rate (RR) by the mRECIST for treatment of uHCC patients
timeFrame: up to 3 years
measure: Clinical control Rate (DCR) by the mRECIST for treatment of uHCC patients
timeFrame: up to 3 years
measure: Clinical benefit rate (CBR) by the mRECIST for treatment of uHCC patients
timeFrame: up to 3 years
measure: Treatment pattern of Sorafenib
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Multiple Locations
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: