Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Unresectable Gastric Cancer

Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients With Unresectable Gastric Cancer

Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients with Unresectable Gastric Cancer

To assess the effectiveness and safety of S-1 + Paclitaxel for the peri-operative chemotherapy in Chinese patients with unresectable gastric cancer, so as to further find out the optimal protocol for the peri-operative chemotherapy in the patients with gastric cancer.

Inclusion Criteria:

-Unresectable gastric cancer as proven histologically (AJCC, Version 7) under any following condition: Unable radical excision due to the local metastasis or invasion Metastasis to the lymph node beside the abdominal aorta Non-extensive metastasis to liver (not more than three metastatic foci of radical excision)

• Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary
• Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
• ECOG (Eastern Cooperative Oncology Group) : 0~2
• Age: 18~75 years old
• Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC>4.0×109/L, NEU >1.5×109/L, PLT>100×109/L, BIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value, and CRE<1.2mg/dl
• Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
• Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver)
• Not participating in other study projects before and during the treatment
• Signed the Informed Consent Form

Exclusion Criteria:

• Not conforming to above inclusion criteria
• Distal metastasis to lung, brain and bone (except the liver)
• Ever operation on the stomach
• Operation intolerance due to other systemic basic diseases
• Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment
• Allergy to the drugs in this protocol
• Pregnant or lactating women
• Women at childbearing age and of pregnancy desire during the study