Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma

Inclusion Criteria:

1. Histologically proven squamous cell carcinoma.

2. Tumours are located in the thoracic oesophagus.

3. Age is between 18 years and 70 years.

4. ECOG performance status of 0 or 1.

5. Patients with resectable cT1-4aN+M0 or T3-4aN0M0 disease and residue disease isfound after neoadjuvant chemotherapy plus surgery or cT1-2N0M0 and pathologicallyproven T1-2N+M0 after upfront surgery.

6. No metastatic cervical lymph nodes.

7. R0 resection is achieved by the minimally invasive esophagectomy (MIE) or openMcKeown approach with total two-field lymph nodes dissection or three-field lymphnodes dissection.

8. No prior therapy was administered against other cancers.

9. Adequate bone marrow function: white blood cell count ≥ 4×109/L; absolute neutrophilcount (ANC) ≥ 1.5×109/l; platelets ≥ 100×109/L; haemoglobin ≥ 9 g/dl.

10. Adequate liver function: serum bilirubin ≤ 1.5 × upper limit of normal (ULN);aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 × ULN (ULN as perinstitutional standard).

11. Adequate renal function: glomerular filtration rate ≥ 60 ml/min calculated using theCockcroft-Gault formula.

12. Normal thyroid function.

13. Written consent is obtained.

Exclusion Criteria:

1. Patients receive neoadjuvant chemoradiation therapy.

2. Patients with pathological complete response (pCR).

3. No. of lymph node dissection < 15.

4. Patients with clinical stages T1-2N+M0 and receive upfront surgery.

5. Patients with unresectable disease (bulky metastatic lymph nodes or T4b) and receiveinduction chemotherapy.

6. Patients requiring systemic steroid medication.

7. Patients with severe postoperative complications and not suitable for adjuvanttherapy.

8. Synchronous or metachronous (within 5 years) double cancers.

9. Patients ever received immunotherapy.

10. Active infection requiring systemic therapy.

11. Patients ever received organ transplant or allogenic haemopoietic stem celltransplantation.

12. Patients with human immunodeficiency virus (HIV) infection.

13. Psychiatric disease.

14. Pregnant or lactating women or women of childbearing potential.

15. Hypersensitivity for Sintilimab.