A Study of Intraperitoneal and Intravenous Paclitaxel Plus Apatinib and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous paclitaxel plus apatinib and S-1 in the conversion therapy of gastric cancer with positive exfoliative cancer cells

Official Title
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A Study of Intraperitoneal and Intravenous Paclitaxel Plus Apatinib and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells

Conditions
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Gastric Cancer With Positive Exfoliative Cancer Cells

Intervention / Treatment
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* Drug: apatinib
* Drug: paclitaxel
* Drug: S-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Untreated (e.g. chemotherapy, radiotherapy and other antitumor therapy); Age:18 to 70 years old; Man or female (except pregnant and lactating women); Confirmed to gastric adenocarcinoma; Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive; Blood cell count has to meet the following criteria: WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L; Liver/kidney function has to meet the following criteria: ALT and AST≤2.5*ULN TBIL<1.5*ULN； Serum creatinine ≤1.5*ULN; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Participants were willing to join in this study, good adherence and written informed consent. Exclusion Criteria: Patients with other malignant tumors within 5 years; Metastasis was found to be visible to the naked eye; It has serious or uncontrolled heart diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on); History of psychiatric drugs abuse and can't quit or patients with mental disorders; Patients with severe or uncontrollable mental illness; Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +).Has melena and hematemesis in two months; Pregnant or lactating women; It have serious harm to the patient's safety or affect the patients who have completed the research. The researchers think inappropriate.

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,apatinib and S-1<br> | Drug: apatinib<br>* apatinib：500mg qd po, 28 days is a cycle. preoperative 2 cycles, 2 cycles after surgery.<br>Drug: paclitaxel<br>* Paclitaxel: intraperitoneal paclitaxel 20 mg/m2 and intravenous paclitaxel 50 mg/m2 on days 1 and 8 ，21 days is a cycle. preoperative 3 cycles, 3 cycles after surgery.<br>Drug: S-1<br>* S-1： According to the body surface area, BSA <1.25m2，40mg bid; 1.25m2≤BSA≤1.5m2，50mg bid; BSA >1.5m2, 60mg bid. Take the medicine twice daily for 2 weeks, then suspend for 1 week. preoperative 3 cycles, 3 cycles after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0-resection rate | There was no residual by the microscope | within 3 weeks after surgery | 
| Conversion to negative rate | Exfoliative cytology positive gastric cancer conversion to negative rate. | within 3 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Baseline to measured date of death from any cause | 5years | 
| Progression free survival (PFS) | Baseline to measured date of progression or death from any cause | 5years | 
| Adverse events | Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.The number of Participants with adverse events will be recorded at each treatment visit. | 5 years |