Total Neoadjuvant Therapy Combined With Adebrelimab in Locally Advanced Resectable ESCC

Inclusion criteria

• Sign a informed consent form and voluntarily join this study;
• Esophageal squamous cell carcinoma diagnosed by histopathology or cytology;
• Diagnosed as thoracic esophageal cancer by CT/MRI/EUS and clinically staged as T1b-3N1-2M0 or T3N0M0 (according to AJCC 8th edition);
• Expected to achieve R0 resection;
• Age ≥ 18 years old, regardless of gender;
• ECOG PS 0-1;
• Have not received any anti-tumor treatment for esophageal cancer in the past;
• Plan to undergo surgical treatment after completion of neoadjuvant therapy;
• No surgical contraindications;
• The main organ functions are normal, including:

• Blood routine examination:

neutrocyte count ≥ 1.5 × 109/L Platelet count ≥ 100 × 109/L Hemoglobin ≥ 90 g/L

• Blood biochemistry test:

Total bilirubin ≤ 1.5 × ULN ALT ≤ 2.5×ULN，AST ≤ 2.5×ULN， Serum creatinine ≤ 1.5 × ULN, or creatinine clearance rate ≥ 50 mL/min (Cocheroft Gault formula, see Appendix 2)

• Coagulation function:

INR ≤ 1.5 × ULN APTT ≤ 1.5 × ULN

• Women who have the ability to conceive or men whose spouses have the ability to conceive should use effective contraceptive measures during the study period;
• The subjects showed good compliance and cooperated with follow-up visits;

Exclusion criteria

• Tumors or lymph nodes significantly invade adjacent organs of esophageal lesions;
• Patients with supraclavicular lymph node metastasis;
• Individuals at risk of perforation, fistula, etc;
• There are uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage;
• Poor nutritional status, BMI < 18.5 Kg/m2；
• Have a history of allergies to monoclonal antibodies, any components of Adebrelimab, paclitaxel, cisplatin, or other platinum based drugs in the past;
• Have received or are currently receiving any of the following treatments:

• Any radiotherapy, chemotherapy, or other anti-tumor drugs targeting tumors;
• Within 2 weeks prior to the first use of the investigational drug, immunosuppressive or systemic hormone therapy was being used to achieve immunosuppressive effects;
• Received attenuated live vaccine within 4 weeks prior to the first use of the investigational drug;
• Having undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the investigational drug;
• Suffering from any active autoimmune disease or history of autoimmune disease;
• History of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation;
• There are clinical symptoms or diseases of the heart that have not been well controlled;
• Severe infection (CTCAE>grade 2) occurred within 4 weeks prior to the first use of the investigational drug;
• Discovery of active pulmonary tuberculosis infection through medical history or CT examination;
• Active hepatitis B and hepatitis C exist;
• Diagnosed with other malignant tumors within 5 years prior to the first use of the investigational drug;
• Pregnant or lactating women;
• According to the researchers' assessment, there are other factors that may lead to the forced termination of the study midway.