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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


N/A
18 Years
75 Years
Open (Enrolling)
Both
Stage I Hepatocellular Carcinoma, Stage II Hepatocellular Carcinoma

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

time to recurrence

Outcome Description:

the interval between the initial hepatectomy and date of diagnosis of recurrent HCC

Outcome Time Frame:

1,2,3 years

Safety Issue:

No

Principal Investigator

Feng Shen, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Hepatobiliary Surgery Hospital

Authority:

China: Ministry of Health

Study ID:

EHBH-RCT-2011-002

NCT ID:

NCT01717066

Start Date:

April 2012

Completion Date:

May 2015

Related Keywords:

  • Stage I Hepatocellular Carcinoma
  • Stage II Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • ginsenoside Rg3
  • Carcinoma
  • Recurrence
  • Carcinoma, Hepatocellular

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