A Prospective, Multicenter, Exploratory Study Comparing 2 Cycles Versus 4 Cycles of Adebrelimab Combined With Chemotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Observing the efficacy and safety of 2 cycles versus 4 cycles of Adebrelimab combined with chemotherapy as neoadjuvant treatment for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma.
• Written informed consent must be signed, and the participant must voluntarily join the study.
• Histologically or cytologically confirmed esophageal squamous cell carcinoma.
• Locally advanced thoracic esophageal cancer assessed by CT/MRI/EUS, with clinical staging T1b-4aN+M0 or T2-4N0M0 (T2N0 patients must have high-risk factors such as lymphovascular invasion \[LVI\], tumor size ≥3 cm, or poor differentiation) (according to AJCC 8th edition).
• Expected to achieve R0 resection.
• Age between 18 and 75 years, regardless of gender.
• ECOG Performance Status 0-1.
• No prior treatment for esophageal cancer, including radiotherapy, chemotherapy, or surgery.
• Planning to undergo surgery after completing neoadjuvant therapy.
• No contraindications for surgery.
⁃ Normal major organ functions, including:
∙ \*\*Hematology\*\* (no use of blood components, growth factors, white blood cell stimulants, platelet stimulants, or anemia-correcting drugs within 14 days before the first use of the study drug):
‣ Neutrophil count ≥1.5 × 10\^9/L
‣ Platelet count ≥100 × 10\^9/L
‣ Hemoglobin ≥90 g/L
‣ \*\*Biochemistry\*\*:
‣ Total bilirubin ≤1.5 × ULN
‣ ALT ≤2.5 × ULN, AST ≤2.5 × ULN
‣ Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min
‣ \*\*Coagulation\*\*:
‣ International Normalized Ratio (INR) ≤1.5 × ULN
‣ Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN
⁃ Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours before starting the study drug and must use effective contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for at least 3 months after the last dose. Male participants with a fertile partner must be surgically sterilized or agree to use effective contraception during the study and for 3 months after the last dose.
⁃ Good compliance with the study and cooperation with follow-up.