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

ShenFeng

Status: Completed

Conditions: Stage I Hepatocellular Carcinoma; Stage II Hepatocellular Carcinoma

Treatments: Drug: Placebo; Drug: the ginsenoside Rg3

Study type: Interventional

Funder types: Other

Identifiers

NCT01717066

EHBH-RCT-2011-002

Details and patient eligibility

About

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

Full description

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

Enrollment: 480 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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480 participants in 2 patient groups, including a placebo group

the ginsenoside Rg3

Experimental group

Description:

320 HCCs,the ginsenoside Rg3 capsule,4-8 weeks after surgery, will be taken, 2 capsules, BID, 8 weeks as one cycle, continue taking it until the tumor recurs or until the end date of the study for patients without recurrence

Treatment:

Drug: the ginsenoside Rg3

the placebo

Placebo Comparator group

Description:

160 HCCs as control group with patients who don't receive any adjuvant therapy after liver resection, to compare with the treatment group

Treatment:

Drug: Placebo