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| Name | Class |
|---|---|
| Huazhong University of Science and Technology | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Sun Yat-sen University | OTHER |
| First Affiliated Hospital of Harbin Medical University |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the ginsenoside Rg3 | Experimental | 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 |
|
| the placebo | Placebo Comparator | 160 HCCs as control group with patients who don't receive any adjuvant therapy after liver resection, to compare with the treatment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the ginsenoside Rg3 | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| time to recurrence | the interval between the initial hepatectomy and date of diagnosis of recurrent HCC | 1,2,3 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | the interval between the date of the initial hepatectomy and the date of death or last follow-up | 1,2,3 years |
| Measure | Description | Time Frame |
|---|---|---|
| side effect | the adverse reactions of the application of ginsenoside Rg3,for example:severe dry pharynx | eighteen months |
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:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Feng Shen, MD,PhD | Eastern Hepatobiliary Surgery Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 350005 | China | ||
| Tumor Hospital,Sun Yat-san University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16793023 | Background | 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. doi: 10.1016/j.bcp.2006.04.034. Epub 2006 May 12. | |
| 19624862 | Background | 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. |
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| OTHER |
| First Affiliated Hospital of Fujian Medical University | OTHER |
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| Drug |
|
| Guangzhou |
| Guangdong |
| 510060 |
| China |
| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| Tongji Hospital,Huazhong University of Science & Technology | Wuhan | Hubei | 430032 | China |
| Zhongshan hospital,Fudan University | Shanghai | 200032 | China |
| 18999937 | Background | 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. |
| 18959116 | Background | 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. |
| 9344044 | Background | 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. doi: 10.1023/a:1018491314066. |
| 23053497 | Background | 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. |
| 22366885 | Background | 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. |
| 22634290 | Background | 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. |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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