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Trial Title:
Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer
NCT ID:
NCT01757366
Condition:
Self Efficacy
Conditions: Official terms:
Stomach Neoplasms
Ginsenoside Rg3
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Ginsenoside Rg3 plus First-line Chemotherapy
Description:
Ginsenoside Rg3 20mg 2/day po,patients will receive Ginsenoside Rg3 until progression
XELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4
cycles followed by capecitabine until progression
Arm group label:
experimental
Intervention type:
Drug
Intervention name:
First-line Chemotherapy
Description:
XELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4
cycles followed by capecitabine until progression
Arm group label:
Active Comparator
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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hebei Tumor Hospital
Address:
City:
Shijiazhuang
Zip:
050011
Country:
China
Status:
Recruiting
Contact:
Last name:
Baoen Shan
Phone:
13803343508
Email:
15931166600@126.com
Investigator:
Last name:
Wei Liu
Email:
Principal Investigator
Start date:
December 2012
Completion date:
December 2016
Lead sponsor:
Agency:
Hebei Tumor Hospital
Agency class:
Other
Source:
Hebei Tumor Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01757366
