the Efficacy and Safety of Ginsenoside Rg3 Capsule in Prevention of Postoperative Recurrence of Hepatocellular Carcinoma

• Randomized, double-blind, multi-center, placebo-controlled, parallel-group;
• Subject population: patients undergone radical resection of hepatocellular carcinoma;
• 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

Inclusion criteria

• 18-75 years old,male and female
• Mainly based on the criteria for liver cancer TNM stage I and II (edition 7) and BCLC stage A, the following needs to be satisfied:

• individual tumor larger than or equal to 2 cm and smaller than or equal to 10 cm in the maximum diameter
• multiple tumors with no more than three tumors
• No macroscopic tumor embolus
• ECOG performance state is 0-1
• Child-Pugh grade is A
• The clinical review confirms the absence of recurrence within 8 weeks before the enrollment
• Sign the informed consent

Exclusion criteria

• Pregnant and breast-feeding women
• Patients with severe diseases in the brain, heart,lungs, kidneys and hematological system
• Patients who have received other anti-tumor therapies before the surgery (including liver transplantation, TACE, local tumor ablation, chemotherapy, radiotherapy, molecular targeted therapy and other anti-tumor therapy)
• DDS chemotherapy pump placed in the portal vein during the surgery
• Patients who are participating in other drug trials
• Patients known or suspected to be allergic to ginsenoside, with a history of allergy to biological preparations, allergic constitution or currently in an allergic state;
• With active severe clinical infection
• Epilepsy episode which needs drug therapy
• With a history of allotransplantation;
• With a previous history of tumor in other systems, but except for:

• Carcinoma in situ of cervix
• Basal cell carcinoma after treatment,Superficial bladder cancer (Ta, Tis and T1
• Any cancer after curative treatment no less than three years ago
• Patients with signs or a history of bleeding diathesis
• Patients currently receiving kidney dialysis
• A history of bleeding in the gastrointestinal tract within 30 days, or severe gastroesophageal varices with red signs; with a history of gastroesophageal variceal hemorrhage
• Recurrent HCC
• Patients unable to take drug orally
• Patients inappropriate to participate in the trial upon the investigator's judgment