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

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ClinicalTrials.gov Identifier: NCT01717066

Recruitment Status : Completed

First Posted : October 30, 2012

Last Update Posted : March 31, 2016

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

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

Condition or disease	Intervention/treatment	Phase
Stage I Hepatocellular Carcinoma Stage II Hepatocellular Carcinoma	Drug: the ginsenoside Rg3 Drug: Placebo	Not Applicable

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

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	480 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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
Study Start Date :	April 2012
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	May 2015

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

time to recurrence [ Time Frame: 1,2,3 years ]
the interval between the initial hepatectomy and date of diagnosis of recurrent HCC

Secondary Outcome Measures :

overall survival [ Time Frame: 1,2,3 years ]
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 ]
the adverse reactions of the application of ginsenoside Rg3,for example:severe dry pharynx

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

Yue PY, Wong DY, Wu PK, Leung PY, Mak NK, Yeung HW, Liu L, Cai Z, Jiang ZH, Fan TP, Wong RN. The angiosuppressive effects of 20(R)- ginsenoside Rg3. Biochem Pharmacol. 2006 Aug 14;72(4):437-45. Epub 2006 May 12.

Liu TG, Huang Y, Cui DD, Huang XB, Mao SH, Ji LL, Song HB, Yi C. Inhibitory effect of ginsenoside Rg3 combined with gemcitabine on angiogenesis and growth of lung cancer in mice. BMC Cancer. 2009 Jul 23;9:250. doi: 10.1186/1471-2407-9-250.

Zhang Q, Kang X, Yang B, Wang J, Yang F. Antiangiogenic effect of capecitabine combined with ginsenoside Rg3 on breast cancer in mice. Cancer Biother Radiopharm. 2008 Oct;23(5):647-53. doi: 10.1089/cbr.2008.0532.

Xu TM, Cui MH, Xin Y, Gu LP, Jiang X, Su MM, Wang DD, Wang WJ. Inhibitory effect of ginsenoside Rg3 on ovarian cancer metastasis. Chin Med J (Engl). 2008 Aug 5;121(15):1394-7.

Iishi H, Tatsuta M, Baba M, Uehara H, Nakaizumi A, Shinkai K, Akedo H, Funai H, Ishiguro S, Kitagawa I. Inhibition by ginsenoside Rg3 of bombesin-enhanced peritoneal metastasis of intestinal adenocarcinomas induced by azoxymethane in Wistar rats. Clin Exp Metastasis. 1997 Nov;15(6):603-11.

Lee JY, Jung KH, Morgan MJ, Kang YR, Lee HS, Koo GB, Hong SS, Kwon SW, Kim YS. Sensitization of TRAIL-induced cell death by 20(S)-ginsenoside Rg3 via CHOP-mediated DR5 upregulation in human hepatocellular carcinoma cells. Mol Cancer Ther. 2013 Mar;12(3):274-85. doi: 10.1158/1535-7163.MCT-12-0054. Epub 2012 Oct 10.

Zhang C, Liu L, Yu Y, Chen B, Tang C, Li X. Antitumor effects of ginsenoside Rg3 on human hepatocellular carcinoma cells. Mol Med Rep. 2012 May;5(5):1295-8. doi: 10.3892/mmr.2012.808. Epub 2012 Feb 23.

Park HM, Kim SJ, Kim JS, Kang HS. Reactive oxygen species mediated ginsenoside Rg3- and Rh2-induced apoptosis in hepatoma cells through mitochondrial signaling pathways. Food Chem Toxicol. 2012 Aug;50(8):2736-41. doi: 10.1016/j.fct.2012.05.027. Epub 2012 May 22.


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
First Posted:	October 30, 2012 Key Record Dates
Last Update Posted:	March 31, 2016
Last Verified:	March 2016

Keywords provided by ShenFeng, 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 Ginsenoside Rg3 Antineoplastic Agents, Phytogenic Antineoplastic Agents

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