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Clinical Trial Summary

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.


Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00805896
Study type Interventional
Source Fudan University
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 2008
Completion date December 2010

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