Songyou Granule and Transarterial Chemoembolization for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

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

Status Active, not recruiting

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

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Unresectable

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