Sintilimab Plus NCT or NCRT Versus NCRT for ESCC

Inclusion criteria:

1. Aged 18 to 75, both sexes;
2. Patients with histologically confirmed locally advanced (cT1N2-3M0 or cT2-4aN0-3M0)thoracic esophageal squamous cell carcinoma (8th UICC-TNM stage);
3. Cervical contrast-enhanced CT showed no suspicious metastatic lymph nodes. Imagingexamination showed no systemic metastasis.
4. R0 resection is expected to be achieved;
5. Physical state ECOG 0 ~ 1;
6. No previous antitumor therapy for esophageal cancer, including chemotherapy,radiotherapy (including radiotherapy planned during the study), hormone therapy, andimmunotherapy;
7. Measurable lesions (according to RECIST v1.1);
8. There was no operation contraindications in the evaluation of various organ functionsbefore operation;
9. The following laboratory tests confirm that the bone marrow, liver and kidneyfunctions meet the requirements for study participation:

• Hemoglobin ≥90g/L;
• White blood cell count ≥ lower limit of laboratory normal;
• Neutrophil absolute value (ANC) ≥1.5×109/L;
• Platelet count ≥100×109/L; Total bilirubin ≤1.5× upper limit of normal (ULN);
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN;
• Prothrombin time ≤16 seconds and international normalized ratio ≤1.5×ULN;Creatinine ≤1.5×ULN or Cr clearance ≥50 mL/min (calculated using Cockcroft-Gaultformula);

10. Fertile women must consent to use effective contraception (e.g. intrauterine devices,birth control pills, or condoms) during the study medication period and within 60 daysof the last study medication, have a negative serum pregnancy test within 7 daysbefore study enrollment, and be non-lactating; Men agree that they must use effectivecontraception during the study medication period and for 60 days after the last studymedication;
11. The informed consent must be understood and signed.

Exclusion criteria: Patients who met any of the following criteria were excluded from the study:

1. Malignant tumors other than esophageal cancer (cured localized tumors, includingcervical carcinoma in situ, skin basal cell carcinoma and prostate carcinoma in situ,were not excluded) had occurred within 5 years before randomization; Prostate cancerpatients receiving hormone therapy with DFS for more than 5 years were not excluded).
2. Patients with high blood tendency who had a history of gastrointestinal bleedingwithin 6 months before randomization, or had coagulopathy at the time of enrollment,or were receiving thrombolysis or anticoagulant therapy;
3. Severe cardiovascular and cerebrovascular diseases: • New York Heart Association (NYHA) class II or higher congestive heart failure,unstable angina, myocardial infarction, poorly controlled arrhythmias, orcerebrovascular accidents within 12 months before randomization. LVEF (left ventricular ejection fraction) <50% on echocardiography. Corrected QTinterval (QTc) >480ms (calculated using Fridericia's method; if QTc was abnormal,three consecutive tests were performed at 2 min intervals and the mean value wastaken). Medically difficult to control hypertension (systolic blood pressure ≥150 mmHg and/ordiastolic blood pressure ≥100mmHg) (based on the average of ≥2 measurements). • A previous hypertensive crisis or hypertensive encephalopathy.
4. Previous history of interstitial lung disease or pneumonia requiring steroid treatmentat enrollment;
5. Had active tuberculosis at the time of randomization, or had receivedanti-tuberculosis therapy within 1 year before randomization;
6. Asthma at random requiring intermittent use of bronchodilators or other medicalinterventions;
7. Patients with infectious diseases requiring systemic treatment (oral or intravenousadministration) within 4 weeks before randomization; for active hepatitis, effectivetreatment was required before enrollment;
8. Severe unhealed wounds, active ulcers, and untreated fractures at random;
9. Combined with other inoperable conditions;
10. The previous operation resulted in the inability to use stomach instead of esophagusto reconstruct the digestive tract in this operation;
11. Was receiving systemic steroid therapy (more than 10mg of prednisone daily orequivalent) or other immunosuppressive agents during the 2 weeks prior torandomization;
12. Severe allergy to chemotherapy drugs (albumin paclitaxel or cisplatin) or anymonoclonal antibody;
13. Has had an active autoimmune disease requiring systemic treatment (i.e.,immunomodulatory drugs, corticosteroids, or immunomodulatory drugs) in the past 2years; However, replacement therapy (e.g., thyroxine, insulin, or replacement therapywith physiologic corticosteroids for adrenal or pituitary insufficiency) is notconsidered systemic therapy and is allowed for use and enrollment;
14. Previous organ transplant recipients;
15. If HBsAg(+) and/or HBcAb(+) are required, HBV DNA must be < 500IU/mL. (If the lowerlimit of the local center's minimum detectable value is higher than 500IU/mL, afterdiscussion with the sponsor, Enrollment was determined on a case-to-case basis) andcontinued to receive effective anti-HBV therapy that was already in use during thestudy period, or entecavir or tenofovir therapy was started prior to study medication;
16. Hcv-rna testing should be performed if HCV antibody is positive, and HCV-RNA>10^3 copynumber /mL should be excluded;
17. Co-infection with HIV;
18. In the judgment of the investigator, there are other circumstances that are notsuitable for participating in the study.