TACE is widely used in patients with unresectable HCC. However, it is a non-curative approach; thus ,strategies to further improve the survival of these patients are needed. Sorafenib is regarded as standard treatment for advanced HCC. It is the first systemic therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that the combination of TACE with sorafenib could improve the survival of patients with unresectable HCC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
After obtaining arterial access,a diagnostic visceral arteriogram will be performed to demonstrate arterial supply to the tumor and the presence of variant arterial anatomy.After having positioned the catheter within the artery feeding tumor,the chemoembolization mixture will be infused into th e artery until stagnant flow is observed.
All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study
Shandong Medical Imaging Research Institute
Jinan, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
the Affiliated Hospital of Medical College Qingdao University
Qingdao, Shandong, China
Time to Progression
Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week
Time frame: 1 year
FACT-Hep
FACT-Hep is a chart established to evaluate the life quality of patients with HCC every 4 weeks
Time frame: six months
Disease control rate
CR+PR+SD
Time frame: six months after TACE
Safety
Number of participants with adverse events as a measure of safety and tolerability(According to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)
Time frame: six months
PFS and OS
The overall survival is defined as time from randomization to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period,respectively
Time frame: two years
Number of TACE sessions and the interval time between two TACE sessions
Time frame: 2 years
AFP
Time frame: six months
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Yantai Yuhuangding Hospital
Yantai, Shandong, China