Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer

Inclusion Criteria: ・ Eligibility criteria 1. Histological diagnosis of gastric adenocarcinoma. 2. Measurable or assessable lesions. 3. Age: 18 \~ 75 years. 4. Performance Status (ECOG): 0 \~ 2. 5. No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period \>4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy. 6. No history of treatment with CPT-11 or S-1. 7. No history of radiotherapy to the abdomen. 8. Oral intake of S-1 is possible. 9. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine \<1.5 mg/dl (but if it is 1.0 \~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes). (10) Predicted survival for \>3 months. (11) Able to give written informed consent Exclusion Criteria: \-