NCT00805896

Songyou Granule and Transarterial Chemoembolization for Hepatocellular Carcinoma

Effectiveness and Safety Study of TACE Plus Oral Songyou Granule for Unresectable HCC

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Hepatocellular Carcinoma
• Unresectable

Interventions

Type	Name	Description
DRUG	Songyou	4g/pack
DRUG	placebo	4g/pack

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-12-10
• Last updated: 2008-12-31

Locations

2 sites across 1 country: China