Esophageal Cancer
Conditions
Interventions
Resectable esophageal cancer:Carrelizumab plus preoperative chemotherapy
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old, no gender limit; 2. Patients with esophageal squamous cell carcinoma with resectable margins; 3. ECOG:0-1; 4. Estimated survival time >=12 weeks; 5. Within 7 days before treatment, the main organ functions met the following criteria: (1) Blood routine examination standard (without blood transfusion within 14 days); 1) Hemoglobin (HB)>=90g/L; 2) ANC>=1.5×10^9/L; 3) PLT>=80×10^9/L; (2) Biochemical examination: 1) ALB>=30g/L; 2) ALT and AST =60ml/min; 6. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= the lower limit of normal value (50%); 7. Women of childbearing age should be those who agree to use contraception (e.g. intrauterine device, contraceptive or condom) during the study period and within 6 months after the end of the study; they must be non-lactating patients with negative serum or urine pregnancy test within 7 days before study enrollment; men should agree to use contraception during the study period and within 6 months after the end of the study period; 8. Patients voluntarily participated in the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. patients who are allergic to paclitaxel and platinum or have metabolic disorders; 2. Patients with brain metastases; 3. Patients with any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma in childhood has been completely alleviated, adults do not need any intervention can be included; patients need to be treated Asthma with medical intervention by bronchodilators could not be included; 4. Patients using immunosuppressant or systemic hormone therapy to achieve the purpose of immunosuppression (dose > 10 mg/day prednisone or other therapeutic hormones), and continue to use it within 2 weeks before enrollment; 5. Patients with any severe and/or uncontrollable diseases, including Patients with poor blood pressure control (systolic blood pressure >=150mmHg or diastolic blood pressure >=100mmHg); patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QT interval >=480ms) and grade I cardiac insufficiency; 6. Active or uncontrolled severe infection; 7. Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA >= 0^4 copies/ml or 2000iu/ml) or hepatitis C (HCV-RNA is higher than the detection limit of the analytical method with positive HCV antibody); 8. Routine urine examination showed that urine protein was >= + +, and 24-hour urine protein was more than 1.0g; 9. Pregnant or lactating women; Patients with other malignancies within 11.5 years (excluding cured basal cell carcinoma of skin and carcinoma in situ of the cervix); 10. Patients with other malignant tumors within 11.5 years (except for cured basal cell carcinoma of skin and carcinoma in situ of cervix); 11. Those who have a history of psychotropic drug abuse and can not give up or have mental disorders; 12. Patients who participated in clinical trials of other drugs within four weeks; 13. According to the judgment of the researcher, there are patients with accompanying diseases that seriously endanger the safety of patients or affect the completion of the study; 14. The researcher thinks that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response,pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main pathological remission,MPR;Surgical conversion rate;Safety;Perioperative complications; | — |
Countries
China
Contacts
Public ContactXiangnan Li
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed