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

Launched by SHENFENG · Oct 29, 2012

Keywords

ClinConnect Summary

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 Placeb...

Gender

ALL

Eligibility criteria

• 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:
• • 1. individual tumor larger than or equal to 2 cm and smaller than or equal to 10 cm in the maximum diameter
• • 2. multiple tumors with no more than three tumors
• • 3. 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:
• • 1. Carcinoma in situ of cervix
• • 2. Basal cell carcinoma after treatment,Superficial bladder cancer (Ta, Tis and T1
• • 3. 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

Trial Officials