Esophageal Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, both men and women; 2. Esophageal squamous cell carcinoma was confirmed by endoscopic biopsy before operation; 3. No distant metastasis; The preoperative clinical stage was stage II~III, and all patients could receive radical resection of esophageal cancer; 4. No contraindications to esophagectomy; 5. ECOG 0~1; 6. The expected survival period is >=6 months; 7. The function of the vital organs meets the following requirements (no blood components or cell growth factors are allowed to be used 2 weeks before the study begins) : (1) Absolute neutrophil count (ANC) >=1.5x10^9/L; (2) Platelets >=80x10^9/L; (3) Hemoglobin >=8g/dL; (4) WBC >=4.0x10^9/L; (5) Bilirubin =2.5 ULN; (6) Serum Cr = 50mL/min (Cockcroft-Gault formula); (7) Normal thyroid function; 8. No serious history of drug allergy; 9. Women of child-bearing age must undergo a pregnancy test (serum or urine) within 7 days of enrollment, which is negative, and are willing to use appropriate contraception during the trial and within 8 weeks of the last administration of apatinib.For men, surgical sterilization or consent to appropriate contraceptive methods during the trial and within 8 weeks of the last administration of apatinib should be provided; 10. Subjects voluntarily participate in this study.Signed informed consent, good compliance, with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who have received previous chemotherapy or other anti-tumor treatments; 2. Patients allergic to drugs such as apatinib, paclitaxel, cisplatin, etc.; 3. Patients with high blood pressure who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure >140 mmHg / diastolic blood pressure > 90 mmHg); 4. Patients with grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval prolongation in men >= 450ms, women >= 470 ms); 5. According to NYHA standard III-IV cardiac dysfunction or echocardiography: patients with LVEF (left ventricular ejection fraction) = ++ or confirmed 24-hour urine protein quantitation > 1.0g; 10. Abnormal blood coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), patients with bleeding tendency or receiving thrombolytic or anticoagulant therapy; 11. A patient who has undergone a major surgical wound without healing within 4 weeks; 12. Patients with symptomatic central nervous system metastasis; 13. Patients who have been diagnosed with other malignant tumors within 5 years prior to the first use of the study drug, and have been treated with effective treatment of cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or effectively resected orthotopic cervical cancer and/or breast cancer; 14. Pregnant or lactating women; patients with fertility who are unwilling or unable to take effective contraceptives; 15. The investigator considers any patient who is not suitable for entering other factors of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;DFS;OS;QoL;R0 resection rate;AE; | — |
Countries
China
Contacts
Anyang City Oncology Hospital