A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of Ginsenoside Rg3 Capsule in Prevention of Postoperative Recurrence of Hepatocellular Carcinoma
1. Randomized, double-blind, multi-center, placebo-controlled, parallel-group;
2. Subject population: patients undergone radical resection of hepatocellular carcinoma;
3. Active drug group:
Ginsenoside Rg3 group: general treatment + ginsenoside Rg3 Control group (placebo group):
general treatment + placebo 4.Method of group assignment: 5research centers,
central-block-stratified randomization, a ratio of active drug group to control group: 2:1
5.Dose and mode of administration: Ginsenoside Rg3 group: ginsenoside Rg3 20mg BID, two
months as one cycle, continue until recurrence occurs Placebo Group: placebo, 2 capsules,
BID, continue until recurrence occurs 6.Study period: Screening phase: screening for
enrollment within 8 weeks after the radical resection Follow up: review every 2-3 months
following the surgery Post-trial investigation: within 28 days after the trial is ended or
the recurrence occurs
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
time to recurrence
the interval between the initial hepatectomy and date of diagnosis of recurrent HCC
1,2,3 years
No
Feng Shen, MD,PhD
Principal Investigator
Eastern Hepatobiliary Surgery Hospital
China: Ministry of Health
EHBH-RCT-2011-002
NCT01717066
April 2012
May 2015
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