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Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer
Conditions
Self Efficacy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: Ginsenoside Rg3 plus First-line Chemotherapy
Type: Drug
Name: First-line Chemotherapy
Type: Drug
Overall Status
Recruiting
Summary
Safety and Efficacy of Ginsenoside Rg3 in Combination with First-line Chemotherapy in Advanced Gastric Cancer.The purpose of this study is to assess the safety of Ginsenoside Rg3 in advanced gastric cancer, and whether it improves the efficacy of first-line chemotherapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
1. Signed informed consent form
2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
3. Histologically or cytologically confirmed gastric cancer;
4. At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
5. Life expectancy of at least 3 months;
Exclusion Criteria:
1. Received any prior treatment including Ginsenoside Rg3;
2. Active or uncontrolled infection;
3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
4. Pregnant or lactating women.
1. Signed informed consent form
2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
3. Histologically or cytologically confirmed gastric cancer;
4. At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
5. Life expectancy of at least 3 months;
Exclusion Criteria:
1. Received any prior treatment including Ginsenoside Rg3;
2. Active or uncontrolled infection;
3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
4. Pregnant or lactating women.
Location
Hebei Tumor Hospital
Shijiazhuang, Hebei, China
Status: Recruiting
Contact: Baoen Shan - 13803343508 - 15931166600@126.com
Start Date
December 2012
Completion Date
December 2016
Sponsors
Hebei Tumor Hospital
Source
Hebei Tumor Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page