Songyou Granule is a mixture of 6 herbs. Vitro and vivo studies showed that Songyou Granule can inhibit HCC cells grow, and HCC metastasis. Hypothesis of this study is that TACE plus Songyou Granule will improve outcome in patients with advanced hepatocellular carcinoma (HCC) compared with TACE.
Primary outcome Measures: To evaluate the effect of TACE plus Songyou Granule or TACE plus placebo on TTP Secondary Outcome Measures: * Overall survival (OS) * Progression Free Survival (PFS) * The overall response rate * Time to symptomatic Progression * In an exploratory manner the relative TTP, TTSP, RR and overall survival between the 2 study populations * Overall response duration and time to objective response * Overall disease control rate * The safety, tolerability, and adverse event profiles of the two treatment regimens used in this trial Enrollment: 260 Study Start Date: January 2009 Study Completion Date: December 2010 Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
260
Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Liver Cancer Institute and Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Time to tumor progression(TTP)
Time frame: Dec 2008 to Dec 2010
Overall survival (OS)
Time frame: Dec 2008 to Dec 2010
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