the Efficacy and Safety of Ginsenoside Rg3 Capsule in Prevention of Postoperative Recurrence of Hepatocellular Carcinoma
This study is currently recruiting participants.
Verified November 2012 by Eastern Hepatobiliary Surgery Hospital
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
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT01717066
First received: October 26, 2012
Last updated: November 19, 2012
Last verified: November 2012
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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:
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:
- 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
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| 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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717066
Contacts
| Contact: Kui Wang, MD | 65564166 ext 875242 | yklwk@yahoo.com.cn |
Locations
| China, Fujian | |
| The First Affiliated Hospital of Fujian Medical University | Recruiting |
| Fuzhou, Fujian, China, 350005 | |
| Contact: Jing-feng Liu, MD 13905029580 drjingfeng@yahoo.com.cn | |
| Contact: Shun-feng Luo, MD 13665003267 494782606@qq.com | |
| 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 cms@21cn.com | |
| Contact: Li Xu, MD 13527656798 daughsea@hotmail.com | |
| 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 liulianxin@medmai.com.cn | |
| Contact: Shu-geng Zhang, MD 15945965885 shugeng517@163.com | |
| 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 chenxp@medmail.com.cn | |
| Contact: Peng Zhu, MD 13907170712 zhupeng@medmail.com.cn | |
| Principal Investigator: Xiao-ping Chen, MD,PhD | |
| China | |
| Zhongshan hospital,Fudan University | Recruiting |
| Shanghai, China, 200032 | |
| Contact: Jia Fan, MD,PhD 13601669720 jiafan99@@yahoo.com | |
| Contact: Yong-shen Xiao, MD 13764317748 yshxiao@163.com | |
| Principal Investigator: Jia Fan, MD,PhD | |
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: | 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 Recurrence Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Disease Attributes |
Pathologic Processes Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 16, 2013