Surveillance of Peripheral Blood of Lymphocyte and Immunocyte in Neoadjuvant Therapy Patients With Esophageal Squamous Cell Carcinoma (pLINE)

Inclusion Criteria:

• 1. Histologically confirmed locally advanced resectable thoracic ESCC; and requires esophagectomy alone or neoadjuvant chemoradiotherapy combined surgery treatment; Clinical stage T1-3N2-3M0 (AJCC 8 TNM classification);
• 2. At least one measurable lesion in accordance with RECIST 1.1;
• 3. Have a performance status of 0 or 1 on the ECOG Performance Scale;
• 4. Expected survival time is greater than 6 months;
• 5. Good organ function level: Hematology: white blood cell ≥3×10^9/L, neutrophil ≥1.5×10^9/L, hemoglobin ≥90 g/L and platelet ≥100×10^9/L; hepatic function: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN), or total bilirubin > ULN, but direct bilirubin ≤ULN, ALT, AST ≤2.5 times the upper limit of normal value; Renal function: serum creatinine ≤1.5 times of ULN; Coagulation function: international normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5 x ULN;
• 6. The electrocardiograph was generally normal, and the left ventricular ejection fraction (LVEF) was ≥50%, Or the myocardial enzyme spectrum is in the normal range;
• 7. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) in the normal range; If baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 in the normal range will also be enrolled;
• 8. Female subjects of childbearing potential have a negative pregnancy test and must agree to take effective contraceptive measures during the study period and within 3 months after the last dose;
• 9. Be willing and able to provide written informed consent/assent for the trial.

Exclusion Criteria:

• 1. Patients with possible tracheoesophageal fistula or aortic esophageal fistula;
• 2. Patients with active autoimmune disease or documented autoimmune disease or symptoms requiring systemic hormone therapy or anti-autoimmune drug therapy;
• 3. Patients with immunodeficiency or who were still receiving systemic steroid hormone therapy (prednisone > 10 mg/ day or other equivalent drugs) or other forms of immunosuppressive therapy 7 days prior to the first dose of neoadjuvant therapy in this study;
• 4. Received anti-tumor therapy, including but not limited to chemotherapy, radiotherapy, immunotherapy, and targeted therapy, within 28 days prior to initial administration;
• 5. Patients with active infection who still required systemic treatment 7 days before the first dose of neoadjuvant therapy in this study;
• 6. Uncontrolled brain metastases;
• 7. Patients with interstitial lung disease, non-infectious pneumonia, or pulmonary fibrosis;
• 8. Patients with active tuberculosis (TB), who is receiving anti-TB treatment or who has received anti-TB treatment within 1 year before the first drug use
• 9. Patients with uncontrolled diabetes (fasting blood glucose ≥CTCAE level 2);
• 10. Peripheral neuropathy of degree II or above was found within 4 weeks before enrollment;
• 11.Patients who have received a foreign organ or stem cell transplant in the past;
• 12. Patients with allergies to the drugs or related ingredients in this study;
• 13. Patients with any serious or unstable medical condition or mental illness;
• 14. History of drug abuse or dependence;
• 15. Major organ disorders or diseases: liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis, etc;
• 16. History of other malignancies within 5 years (except for cured cervical cancer or basal cell carcinoma of the skin);
• 17. Patients who also participated in other clinical trials;
• 18. The researchers did not consider the patients suitable for any medical condition under study.