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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Eastern Hepatobiliary Surgery Hospital.
Recruitment status was  Recruiting
Huazhong University of Science and Technology
Shanghai Zhongshan Hospital
Sun Yat-sen University
First Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Fujian Medical University
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital Identifier:
First received: October 26, 2012
Last updated: November 19, 2012
Last verified: November 2012

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

Condition Intervention
Stage I Hepatocellular Carcinoma
Stage II Hepatocellular Carcinoma
Drug: the ginsenoside Rg3
Drug: Placebo

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

Resource links provided by NLM:

Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:
  • time to recurrence [ Time Frame: 1,2,3 years ] [ Designated as safety issue: No ]
    the interval between the initial hepatectomy and date of diagnosis of recurrent HCC

Secondary Outcome Measures:
  • overall survival [ Time Frame: 1,2,3 years ] [ Designated as safety issue: Yes ]
    the interval between the date of the initial hepatectomy and the date of death or last follow-up

Other Outcome Measures:
  • side effect [ Time Frame: eighteen months ] [ Designated as safety issue: Yes ]
    the adverse reactions of the application of ginsenoside Rg3,for example:severe dry pharynx

Estimated Enrollment: 480
Study Start Date: April 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: the ginsenoside Rg3
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
Drug: the ginsenoside Rg3
Other Name: Shen Yi capsule
Placebo Comparator: the placebo
160 HCCs as control group with patients who don't receive any adjuvant therapy after liver resection, to compare with the treatment group
Drug: Placebo

Detailed 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


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01717066

Contact: Kui Wang, MD 65564166 ext 875242

China, Fujian
The First Affiliated Hospital of Fujian Medical University Recruiting
Fuzhou, Fujian, China, 350005
Contact: Jing-feng Liu, MD    13905029580   
Contact: Shun-feng Luo, MD    13665003267   
Principal Investigator: Jing-feng Liu, MD         
China, Guangdong
Tumor Hospital,Sun Yat-san University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Min-shan Chen, MD    13902241061   
Contact: Li Xu, MD    13527656798   
Principal Investigator: Min-shan Chen, MD         
China, Heilongjiang
The First Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Lian-xin Liu, MD,PhD    13845159888   
Contact: Shu-geng Zhang, MD    15945965885   
Principal Investigator: Lian-xin Liu, MD,PhD         
China, Hubei
Tongji Hospital,Huazhong University of Science & Technology Recruiting
Wuhan, Hubei, China, 430032
Contact: Xiao-ping Chen, MD,PhD    1346120063   
Contact: Peng Zhu, MD    13907170712   
Principal Investigator: Xiao-ping Chen, MD,PhD         
Zhongshan hospital,Fudan University Recruiting
Shanghai, China, 200032
Contact: Jia Fan, MD,PhD    13601669720   
Contact: Yong-shen Xiao, MD    13764317748   
Principal Investigator: Jia Fan, MD,PhD         
Sponsors and Collaborators
Huazhong University of Science and Technology
Shanghai Zhongshan Hospital
Sun Yat-sen University
First Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Fujian Medical University
Principal Investigator: Feng Shen, MD,PhD Eastern Hepatobiliary Surgery Hospital
  More Information


Responsible Party: ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery Hospital Identifier: NCT01717066     History of Changes
Other Study ID Numbers: EHBH-RCT-2011-002
Study First Received: October 26, 2012
Last Updated: November 19, 2012
Health Authority: China: Ministry of Health

Keywords provided by Eastern Hepatobiliary Surgery Hospital:
Hepatocellular Carcinoma
ginsenoside Rg3

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial processed this record on October 09, 2015