Self Efficacy
Conditions
Brief 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.
Interventions
DRUGGinsenoside 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
XELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4 cycles followed by capecitabine until progression
Sponsors
Hebei Tumor Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | 1 years |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | 1 year |
| Overall Survival (OS) | 3 year |
Countries
China
Contacts
Primary ContactBaoen Shan
Outcome results
None listed