gastric cancer
Conditions
Interventions
Case series:apatinib combined with with XELOX regimen
Sponsors
The First Affliliated Hospital With Nangjing Medical University(Jiangsu Province Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old, male or female; 2. It is diagnosed as gastric adenocarcinoma by histopathology and/or cytology, and is a locally advanced gastric cancer patient with radical resection (T2 N+ M0 II to T4b Nany M0 IV); 3. Did not receive pre-anti-tumor treatment (radiation, chemotherapy, targeted therapy, immunotherapy, etc.); 4. ECOG PS 0-1 points; 5. Estimated survival time = 6 months; 6. The heart function is good before enrollment, there is no myocardial infarction within half a year, hypertension, other coronary heart disease is currently within the controllable range; 7. The main organs function normally and meet the following requirements: (1) Blood routine examination, need to meet (no blood transfusion within 14 days): HGB = 90g/L; ANC = 1.5×10^9/L; PLT = 100×10^9/L. (2) Biochemical examinations must meet the following criteria: BIL < 1.5 × ULN; ALT and AST < 2.5 × ULN; Serum Cr = 1 × ULN, endogenous creatinine clearance = 50ml / min (Cockcroft-Gault formula); 8. Before entering the group, there are no other uncontrollable benign diseases such as lung, liver, kidney, infection, etc.; 9. Patients voluntarily join the study and sign an informed consent form (ICF); 10. Women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and voluntarily use the appropriate method of contraception during the observation period and within 8 weeks after the last administration of the apatinib tablet; for men, Surgical sterilization should be performed, or consent should be used for contraception during the observation period and within 8 weeks after the last administration of the apatinib tablets.
Exclusion criteria
Exclusion criteria: 1. Those who suffer from high blood pressure and cannot be reduced to the normal range by antihypertensive drugs (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 2. Previously suffered from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval = 450 ms, women = 470 ms); according to NYHA criteria, grades III to IV Cardiac dysfunction, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) 1.0g); 4. The investigator believes that the risk of gastrointestinal bleeding may occur; Those who have undergone major surgery within 5.30 days; 6. Long-term use of antiplatelet drugs such as aspirin and clopidogrel, or anticoagulants such as warfarin; 7. abnormal blood coagulation, with bleeding tendency; 8. According to the investigator's judgment, there are other serious patients who are at risk to the patient's safety or affect the patient's accompanying disease to complete the study; 9. Pregnant or lactating women; 10. The investigator believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological response rate;R0 resection rate;pCR;1-year disease-free survival rate;2-year disease-free survival rate;2-year overall survival rate;3-year overall survival rate;DCR;ORR; | — |
Countries
China
Contacts
Public ContactZekuan Xu
The First Affliliated Hospital With Nangjing Medical University
Outcome results
None listed