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The purpose of this study is to investigate the efficacy and safety of HIPEC plus apatinib and S-1 in the conversion therapy of gastric cancer with positive exfoliative cancer cells
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apatinib paclitaxel S-1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel apatinib S-1 | Drug | HIPEC: 43℃, 60min. the drug is paclitaxel : 70mg/m2 d1 d3 d5, The interval is not less than 24h , A total of three times. apatinib:500mg qd po, 28 days is a cycle.preoperative 2 cycles, 2 cycles after surgery. 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- 1. Patients with other malignant tumors within 5 years; 2. Metastasis was found to be visible to the naked eye; 3. 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); 4. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 5. Patients with severe or uncontrollable mental illness; 6. 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; 7. Pregnant or lactating women; 8. It have serious harm to the patient's safety or affect the patients who have completed the research.
9. The researchers think inappropriate.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qun Zhao | Contact | 13930162111 | Zhaoqun516@126.com |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 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 |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |