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Conditions
Interventions
experimental group:apatinib+SOX
Sponsors
Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects who voluntarily participate in and sign the informed consent in writing; 2. People aged 18-75 years, regardless of gender; 3. Patients with gastric adenocarcinoma confirmed by histopathology and / or cytology and with locally advanced gastric cancer (t3-4nxm0) that can be resected radically; 4. Subjects with ECoG score of 0-1; 5. Patients without previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6. Patients whose expected survival time is more than 6 months; 7. The subjects with good cardiac function before enrollment had no myocardial infarction within half a year, and hypertension and other coronary heart diseases were within the control range; 8. The subjects with normal function of main organs should meet the following requirements: (1) Blood routine examination should meet the following requirements: Neutrophils >= 1.5 x 10^9 / L; Hemoglobin >= 9g / dl; Platelets >= 100 x 10^9 / L; (2) Blood biochemical examination should meet the following requirements: Total bilirubin <= 1.5 times the upper limit of normal value; Ast (SGOT) and ALT (SGPT) <= 2.5 times the upper limit of normal value; Creatinine <= 1.5 times the upper limit of normal value. 9. Patients without other uncontrollable benign diseases, such as lung, liver, kidney infection, etc; 10. Women of childbearing age must be patients who have received pregnancy test (serum) within 7 days before enrollment, and the results are negative, and they are willing to use appropriate contraceptive methods during the trial period and 8 weeks after the last administration of the trial drug; for men, they should be surgical sterilization or agree to use appropriate contraceptive methods during the trial period and 8 weeks after the last administration of the trial drug; 11. Subjects who did not participate in other clinical studies before and during treatment; 12. Voluntarily join the study, sign informed consent, good compliance, cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with hypertension who can not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 2. Patients with previous severe cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval >= 450 ms for male and >= 470 MS for female); cardiac insufficiency of grade III-IV according to NYHA standard, or left ventricular ejection fraction (LVEF) 1.0g) 4. Patients with known HER2 positive ( or HER2 borderline results , fish confirmed as positive) were excluded; patients with unknown HER2 Yin and Yang could be enrolled 5. The researchers think that there may be a risk of bleeding; 6. Long term use of aspirin, clopidogrel and other antiplatelet drugs, or warfarin and other anticoagulant drugs; 7. Patients with abnormal coagulation function and bleeding tendency; 8. Patients with distant metastasis; 9. Fertile men or women are unwilling to take contraceptive measures in the trial, and women are pregnant or lactating; 10. Patients with multiple factors affecting oral medication (such as inability to swallow, persistent uncontrollable nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.); 11. Patients with allergic reactions to the drugs used; 12. According to the judgment of the researcher, there are other factors that may cause the subject to be forced to terminate the study, such as suffering from other serious diseases (including mental illness) requiring combined treatment, family or social factors, which may affect the safety of the subject or the collection of experimental data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year DFS%; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;3-year OS;5-year OS;Safety; | — |
Countries
China
Contacts
Public ContactSong Jun
Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed