A Clinical Trial of S-1 Plus Cisplatin Versus 5-FU Plus Cisplatin in Patients With Unresectable or Advanced Gastric Cancer
- Histologically confirmed adenocarcinoma of the stomach with inoperable locally
advanced or recurrent and/or metastatic disease.
- Male or female.
- Age 18 -75.
- Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant
therapy is allowed if at least 6 months has elapsed between completion of
adjuvant/neoadjuvant therapy and enrolment into the study).
- Measurable disease, according to the Response Evaluation Criteria in Solid
- ECOG Performance status 0, 1 or 2
- Haematological, Biochemical and Organ Function: Neutrophil count >2.0 × 10 9/L,
platelet count > 100 ×10 9/L. Serum bilirubin< 1.5 × upper limit of normal (ULN); or,
AST or ALT < 2.5 × ULN (or < 5 × ULN in patients with liver metastases); or,
alkaline phosphatase< 2.5 × ULN (or > 5 × ULN in patients with liver
metastases,Creatinine clearance > 60 mL/min.
- Signed informed consent.
- prior adjuvant/neoadjuvant therapy more than two regiments.
- Received any investigational drug treatment within 30 days of start of study
- Patients with active gastrointestinal bleeding.
- Neurological toxicity ≥ grade 2 NCI-CTCAE.
- Other malignancy within the last 5 years, except for carcinoma in situ of the cervix,
or basal cell carcinoma.
- History or clinical evidence of brain metastases.
- Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly
- Pregnancy women.
- Subjects with reproductive potential not willing to use an effective method of
- Patients with known active infection with HIV.
- Known hypersensitivity to any of the study drugs.