Esophageal Cancer Clinical Trials

• Provided written informed consent and voluntarily enrolled in this study;

• Aged 18-75 years, male or female;

• Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC);

• Clinical stage: cT1b-cT2N+M0 or cT3-cT4a any N M0;

• At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria: long axis ≥10 mm on spiral CT for target lesions, or short axis ≥15 mm for malignant lymph nodes;

• Predicted to be eligible for R0 resection;

• Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 (see Appendix 1);

• No prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.;

• Planned to undergo surgical resection after completion of neoadjuvant therapy;

• No contraindications to surgery;

• Adequate organ function, as defined below:

‣ Hematologic parameters (no blood products, colony-stimulating factors, leukocyte-raising agents, platelet-raising agents, or anti-anemia agents permitted within 14 days prior to the first dose of study drug):

‣ White blood cell (WBC) count ≥ 3.0×10⁹/L Absolute neutrophil count (ANC) ≥ 1.0×10⁹/L Platelet count ≥ 80×10⁹/L Hemoglobin ≥ 90 g/L

⁃ Blood biochemistry:

‣ Total bilirubin ≤ 1.5×ULN Alanine transaminase (ALT) ≤ 2.5×ULN; aspartate transaminase (AST) ≤ 2.5×ULN Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-Gault formula, see Appendix 2)

⁃ Coagulation function:

∙ International normalized ratio (INR) ≤ 1.5×ULN Activated partial thromboplastin time (APTT) ≤ 1.5×ULN

• Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 72 hours before initiation of study drug administration, and use effective contraception (e.g., intrauterine device, oral contraceptives, condoms) during the trial and for at least 3 months after the last dose.Male subjects with female partners of childbearing potential must use effective contraception during the trial and for 3 months after the last dose;

• Good subject compliance and willingness to comply with study follow-up requirements.