advanced gastric cancer
Conditions
Interventions
Total:irinotecan, 125 mg/m2 (IV) , day 1
Cisplatin, 60 mg/m 2 (IV), day 2
two weeks as a cycle, up to 6 cycles
Sponsors
Cancer Institute & Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the stomach; 2. Age >=18 years; 3. initially metastatic or received pre-operative chemotherapy; 4. A patient with previous chemotherapy without containing irinotecan or platinum; 5. A patient without another malignant disease; 6. A patient with at least one measurable primary lesion of which the diameter is confirmed in CT or X-ray; 7. ECOG performance status of 0-1; 8. Predictive life span no less than 3 months; 9. A patient with the willingness to comply with the study protocol during the study period and capable of complying with it; 10. adequate organ functions defined as indicated below: WBC>3.5 G/L, ANC>1.5 G/L, Plt >100*10^9/L, HB>10g/dL T.Bil 60ml/min; 11. Patients who previously received radiation therapy meet the following conditions can be included: (1) Measurable lesions must be outside of the radiation field; (2) at least 3 weeks after undergoing spinal or pelvic radiation therapy; (3) all adverse reactions of radiotherapy completely disappeared; (4) radiation therapy used as a topical treatment for pain relief. 12. A patient who signed the informed consent prior to the participation of the study.
Exclusion criteria
Exclusion criteria: 1. A patient who is incapacitated or limited legally; 2. A patient receiving other anti-tumor therapy, including hormone therapy(except for oral contraceptives and physiological replacement), immunotherapy and targeted therapy; 3. A pregnant or lactating patient; 4. A patient who developed uncontrolled serious infection or other uncontrolled serious concomitant diseases; 5. A patient with chronic diarrhea and short bowel syndrome; 6. A patient with Meningeal metastases or brain metastases (confirmed or suspected); 7. A patient with active hepatitis B or C; 8. A patient with history of another malignant disease within past 5 years, except curatively treated basal cell carcinoma of the skin and cervical carcinoma in situ are excluded; 9. A patient who has participated in a clinical trial with other medications or therapy within 4 weeks prior to the initiation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;time to progression; | — |
Countries
China
Contacts
Public ContactHuang Jing
Outcome results
None listed