Back to resultsthe Efficacy and Safety of Ginsenoside Rg3 Capsule in Prevention of Postoperative Recurrence of Hepatocellular Carcinoma (Rg3)
Primary Purpose
Stage I Hepatocellular Carcinoma, Stage II Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the ginsenoside Rg3
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Stage I Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, ginsenoside Rg3
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:
- individual tumor larger than or equal to 2 cm and smaller than or equal to 10 cm in the maximum diameter
- multiple tumors with no more than three tumors
- 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:
- Carcinoma in situ of cervix
- Basal cell carcinoma after treatment,Superficial bladder cancer (Ta, Tis and T1
- 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
Sites / Locations
- The First Affiliated Hospital of Fujian Medical University
- Tumor Hospital,Sun Yat-san University
- The First Affiliated Hospital of Harbin Medical University
- Tongji Hospital,Huazhong University of Science ＆ Technology
- Zhongshan hospital,Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
the ginsenoside Rg3
the placebo
Arm 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
160 HCCs as control group with patients who don't receive any adjuvant therapy after liver resection, to compare with the treatment group
Outcomes
Primary Outcome Measures
time to recurrence
the interval between the initial hepatectomy and date of diagnosis of recurrent HCC
Secondary Outcome Measures
overall survival
the interval between the date of the initial hepatectomy and the date of death or last follow-up
Full Information
NCT ID
NCT01717066
First Posted
October 26, 2012
Last Updated
March 30, 2016
Sponsor
ShenFeng
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
1. Study Identification
Unique Protocol Identification Number
NCT01717066
Brief Title
the Efficacy and Safety of Ginsenoside Rg3 Capsule in Prevention of Postoperative Recurrence of Hepatocellular Carcinoma
Acronym
Rg3
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ShenFeng
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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
Detailed Description
Randomized, double-blind, multi-center, placebo-controlled, parallel-group;
Subject population: patients undergone radical resection of hepatocellular carcinoma;
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Hepatocellular Carcinoma, Stage II Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, ginsenoside Rg3
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
480 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the ginsenoside Rg3
Arm Type
Experimental
Arm 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
Arm Title
the placebo
Arm Type
Placebo Comparator
Arm Description
160 HCCs as control group with patients who don't receive any adjuvant therapy after liver resection, to compare with the treatment group
Intervention Type
Drug
Intervention Name(s)
the ginsenoside Rg3
Other Intervention Name(s)
Shen Yi capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
time to recurrence
Description
the interval between the initial hepatectomy and date of diagnosis of recurrent HCC
Time Frame
1,2,3 years
Secondary Outcome Measure Information:
Title
overall survival
Description
the interval between the date of the initial hepatectomy and the date of death or last follow-up
Time Frame
1,2,3 years
Other Pre-specified Outcome Measures:
Title
side effect
Description
the adverse reactions of the application of ginsenoside Rg3,for example:severe dry pharynx
Time Frame
eighteen months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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:
individual tumor larger than or equal to 2 cm and smaller than or equal to 10 cm in the maximum diameter
multiple tumors with no more than three tumors
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:
Carcinoma in situ of cervix
Basal cell carcinoma after treatment,Superficial bladder cancer (Ta, Tis and T1
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Shen, MD,PhD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
Tumor Hospital,Sun Yat-san University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
Tongji Hospital,Huazhong University of Science ＆ Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430032
Country
China
Facility Name
Zhongshan hospital,Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
16793023
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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the Efficacy and Safety of Ginsenoside Rg3 Capsule in Prevention of Postoperative Recurrence of Hepatocellular Carcinoma
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