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

This study has been completed.
Sponsor:
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
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT01717066
First received: October 26, 2012
Last updated: March 30, 2016
Last verified: March 2016
History of Changes
  Purpose
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:

U.S. FDA Resources

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
Enrollment: 480
Study Start Date: April 2012
Study Completion Date: May 2015
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

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01717066

Locations
China, Fujian
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
China, Guangdong
Tumor Hospital,Sun Yat-san University
Guangzhou, Guangdong, China, 510060
China, Heilongjiang
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
China, Hubei
Tongji Hospital,Huazhong University of Science ＆ Technology
Wuhan, Hubei, China, 430032
China
Zhongshan hospital,Fudan University
Shanghai, China, 200032
Sponsors and Collaborators
ShenFeng
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
Investigators
Principal Investigator: Feng Shen, MD,PhD Eastern Hepatobiliary Surgery Hospital
  More Information

Publications:

Responsible Party: ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT01717066     History of Changes
Other Study ID Numbers: EHBH-RCT-2011-002 
Study First Received: October 26, 2012
Last Updated: March 30, 2016
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 23, 2016