Stage I Hepatocellular Carcinoma Clinical Trial
Official title:
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
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02774161 -
B-mode Ultrasound Imaging in Detecting Early Liver Cancer
|
N/A |