Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer
NCT ID: NCT01757366
Last Updated: 2014-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2012-12-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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experimental
Ginsenoside Rg3 plus First-line Chemotherapy
Ginsenoside Rg3 plus First-line Chemotherapy
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
Active Comparator
First-line Chemotherapy
First-line Chemotherapy
XELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4 cycles followed by capecitabine until progression
Interventions
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Ginsenoside Rg3 plus First-line Chemotherapy
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
First-line Chemotherapy
XELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4 cycles followed by capecitabine until progression
Eligibility Criteria
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Inclusion Criteria
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
2. Active or uncontrolled infection;
3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
4. Pregnant or lactating women.
18 Years
75 Years
ALL
No
Sponsors
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Hebei Tumor Hospital
OTHER
Responsible Party
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Principal Investigators
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Wei Liu
Role: PRINCIPAL_INVESTIGATOR
Hebei Tumor Hospital
Locations
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Hebei Tumor Hospital
Shijiazhuang, Hebei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HBTH102
Identifier Type: -
Identifier Source: org_study_id
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