None listed
Conditions
Interventions
Sponsors
The Second Affiliated Hospital of Xi 'an Jiaotong University
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, male or female; 2. ECOG score 0~1; 3. Patients with esophageal cancer diagnosed by pathology (histology or cytology); 4. According to the 8th edition of clinical tumor TNM stage, the subjects were resectable stage ii-iii esophageal squamous cell carcinoma; 5. Measurable lesions (according to RECIST 1.1 criteria, tumor lesions have a long diameter of 10mm and lymph node lesions have a short diameter of 15mm); 6. Patients who were initially diagnosed with esophageal squamous cell carcinoma before enrolment and had not undergone surgery or targeted therapy through radiotherapy or chemotherapy; 7. Able to eat a liquid diet or above; No pre-esophageal perforation signs; No distant metastasis, can tolerate surgery; 8. Normal or mild to moderate abnormal lung function (VC%>60%, FEV1>1.2 L, FEV1% & gt; 40%, DLco>40%), can tolerate esophageal cancer surgery; 9. Patients with ~ grade heart function and no abnormal daily activities can tolerate esophageal cancer surgery; 10. Major organs function normally, that is, meet the following criteria: (1) Blood routine examination must meet (no blood transfusion, no use of hematopoietic factors and no drug correction within 14 days): 1)anc 1.5x10^9/L; 2)PLT 100x10^9/L; 3)HB 90 g/L. (2) Biochemical tests must meet the following criteria: 1)TBIL <=1.5 ULN; 2)LT AST <=2.5 ULN (5 ULN if abnormal liver function due to liver metastasis); 3)Serum creatinine SCR<=1.5 ULN, endogenous creatinine clearance 50 mL/min(Cockcroft-Gault formula). (3) Coagulation function must conform to INR <=1.5 ULN and APTT <=1.5 ULN. 11. Female subjects of childbearing age must have a serological pregnancy test within 3 days prior to study initiation with negative results and be willing to use a highly effective medically approved contraceptive (e.g., intrauterine contraceptive device or condom) during the study period and within 3 months after the last study administration; For male subjects whose partners are women of reproductive age, they should either be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after the last study dosing 12.The subjects voluntarily joined the study and signed the informed consent. They had good compliance and cooperated with the follow-up; 12. The subjects voluntarily joined the study and signed the informed consent form. They had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Central nervous system metastasis; 2. Have any active autoimmune diseases or a history of autoimmune diseases (as follows, but not limited to: interstitial pneumonia uveitis enteritis hepatitis pituitaritis vasculitis myocarditis nephritis hyperthyroidism reduced thyroid function (can be included after hormone replacement therapy);Patients with vitiligo or childhood asthma who were in complete remission were included without any intervention in adults;Patients requiring bronchodilators for medical intervention were not included; 3. Congenitally or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA 2000 IU/mL), hepatitis C (HCV antibody positive and HCV-RNA above the detection limit of the assay method), or co-infection with hepatitis B and hepatitis C; 4. Use of immunosuppressive drugs within 14 days prior to initial study drug use, excluding nasal and inhaled corticosteroids or physiological dose of systemic steroid hormones (i.e., not more than 10 mg/ day prednisone or its equivalent); 5. Risk of esophageal perforation or esophageal ulcer; 6. Live attenuated vaccine injection within 4 weeks prior to initial administration or planned for the study period; 7. Sufferred from other malignant tumors in the past 3 years; 8. Uncontrolled hypertension (SBP 140 mmHg or diastolic BP 90 mmHg, despite optimal medication); Patients newly diagnosed with angina pectoris within 3 months before screening or patients with myocardial infarction within 6 months before screening; Arrhythmias (including QTCF: 450 ms for men, 470 ms for women) require long-term use of antiarrhythmic drugs and New York Heart Association grade II cardiac insufficiency; 9. People with a history of serious lung or heart disease; 10. Severe infection (e.g., requiring intravenous antibiotic antifungal or antiviral medication) within 4 weeks prior to initial administration, or unexplained fever during screening/prior to initial administration.38.5 C; 11. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 12. Pregnant or lactating women; Fertile patients unwilling or unable to take effective contraceptive measures; 13. Known allergic, hypersensitive or intolerant to the experimental drug and its excipients; 14. Subjects who are participating in other clinical studies or who are taking their first drug less than 4 weeks after the end of the previous clinical study (last drug use), or who have a 5 half-life of the drug in the study; 15. Subject has a known history of psychotropic substance abuse, alcohol abuse or drug abuse; 16. The Investigator considers that there are any conditions that may impair the subject or cause the subject to fail to meet or perform the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission of cases; | — |
Countries
China
Contacts
Public ContactLi Jianzhong
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed