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

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

Detailed Description
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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.

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

Conditions
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Surgically-Created Resection Cavity, Drug Safety

Intervention / Treatment
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* Drug: S-1 + Paclitaxel Chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-1 + Paclitaxel Chemotherapy<br>S-1: 60mg twice daily (after the breakfast and supper) for two weeks, and then suspend for one week. Paclitaxel: 150 mg/m2, iv, 3h, at D1 | Drug: S-1 + Paclitaxel Chemotherapy<br>* Dose of S-1: 60mg bid，Twice daily (after the breakfast and supper) for two weeks, and then suspend for one week. Dose of Paclitaxel: 150 mg/m2, iv, 3h, at D1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radical resection rate | radical resection rate | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number and degree of Adverse Events | 6 months | 
| reaction rate | the reaction rate of chemotherapy | 2 months | 
| overall survival time | the overall survival time | 3 years |