Exploratory Study on the Paclitaxel + S-1 + Oxaliplatin (PSOX) for Locally Advanced or Advanced Gastric Cancer

Study Overview
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Brief Summary
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Explore the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin (PSOX) Chemotherapy in the Patients with Locally Advanced or Advanced Gastric Cancer

Detailed Description
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To assess the Efficiency and safety of Paclitaxel + S-1 + Oxaliplatin(PSOX) in the Patients with Locally Advanced or Advanced Gastric Cancer

Official Title
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Exploratory Study on the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin Chemotherapy in the Patients With Locally Advanced or Advanced Gastric Cancer

Conditions
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Gastric Cancer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma; Locally advanced, or recurrent, or metastasis disease； Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed; Life expectancy of at least 3 months; ECOG score 0-1; Age: 18 70 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; Voluntarily signed the informed consent. Exclusion Criteria: Previously treated with first-line chemotherapy; 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: 70 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: Paclitaxel + S-1 + Oxaliplatin group<br>Paclitaxel: 135 mg/m2, iv, 3h, at D1 ; S-1: 40mg twice daily for patients with a body surface area (BSA) < 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to < 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week; Oxaliplatin: 85 mg/m2, iv, 2h, at D1. | Drug: Paclitaxel + S-1 + Oxaliplatin<br>* Paclitaxel: 135 mg/m2, iv, 3h, at D1. S-1: S-1: 40mg twice daily for patients with a body surface area (BSA) < 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to < 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week. Oxaliplatin: 85 mg/m2, iv, 2h, at D1.<br>* Other names: Paclitaxel + S-1 + Oxaliplatin chemotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate(ORR) | The sum of complete remission (CR) rate and partial remission (PR) rate. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival(PFS) | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months | 2 years | 
| Overall survival(OS) | From date of enrollment until the date of death from any cause, assessed up to 60 months | 2 years | 
| Disease control rate(DCR) | The sum of CR rate, PR rate and stable disease(SD) rate. Response will be measured through first-line treatment completion, up to 1 year | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, S-1, Paclitaxel, Oxaliplatin, Efficiency