Using the subject with hepatocellular carcinoma in the conventional therapy to evaluate the efficacy and safety of ginsenoside Rg3 (20mg BID) and placebo in prevention and treatment of postoperative recurrence of liver cancer,respectively
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
480
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Tumor Hospital,Sun Yat-san University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Tongji Hospital,Huazhong University of Science & Technology
Wuhan, Hubei, China
time to recurrence
the interval between the initial hepatectomy and date of diagnosis of recurrent HCC
Time frame: 1,2,3 years
overall survival
the interval between the date of the initial hepatectomy and the date of death or last follow-up
Time frame: 1,2,3 years
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Zhongshan hospital,Fudan University
Shanghai, China