Effectiveness and Safety Study of TACE Plus Oral Songyou Granule for Unresectable HCC
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)
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Time to tumor progression(TTP)
Dec 2008 to Dec 2010
Yes
Zhao-You Tang, MD
Study Chair
Fudan University
China: Food and Drug Administration
LCI-1001
NCT00805896
December 2008
December 2010
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