Time-of-Day of Immunotherapy Infusion in Neoadjuvant Immunochemotherapy for Thoracic ESCC

Exclusion Criteria20

• Tumor with obvious invasion of adjacent critical structures, such as the aorta or trachea.
• Presence of supraclavicular lymph node metastasis.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• Poor nutritional status with body mass index (BMI) <18.5 kg/m²; patients whose nutritional status is corrected before randomization through supportive care may be considered eligible at the discretion of the principal investigator.
• Known hypersensitivity to monoclonal antibodies, adebrelimab, nab-paclitaxel, cisplatin, or other platinum-based agents.
• Prior or ongoing treatments as follows:
• Any prior anti-tumor therapy, including chemotherapy, radiotherapy, or other anti-cancer drugs;
• Use of systemic immunosuppressive therapy or corticosteroids for immunosuppression (>10 mg/day prednisone or equivalent) within 2 weeks prior to first study drug administration. Inhaled or local steroid use and corticosteroid replacement therapy >10 mg/day prednisone equivalent in patients without active autoimmune disease are permitted;
• Administration of live attenuated vaccines within 4 weeks prior to first study drug administration;
• Major surgery or severe trauma within 4 weeks prior to first study drug administration.
• Active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism (patients on stable hormone replacement therapy may be eligible). Patients with psoriasis or childhood asthma/allergy fully resolved in adulthood and not requiring intervention may be eligible, but those requiring ongoing medical management with bronchodilators are excluded.
• History of immunodeficiency, including positive HIV test, other congenital or acquired immunodeficiency, or history of organ or allogeneic bone marrow transplantation.
• Uncontrolled clinically significant cardiac conditions, including but not limited to:
• NYHA class II or higher heart failure;Unstable angina;Myocardial infarction within 1 year;Clinically significant supraventricular or ventricular arrhythmias inadequately controlled despite intervention.
• Severe infection (CTCAE > grade 2) within 4 weeks prior to first study drug administration requiring hospitalization, including severe pneumonia, bacteremia, or infectious complications. Patients with active pulmonary inflammation on baseline imaging, infection symptoms within 14 days prior to first study drug administration, or requiring oral/IV antibiotics (excluding prophylactic antibiotics) are excluded.
• Active pulmonary tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or history of untreated active tuberculosis more than 1 year prior to enrollment.
• Active hepatitis B (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL) or hepatitis C infection (positive HCV antibody with HCV RNA above the assay detection limit).
• Diagnosis of other malignancies within the past 5 years, except for tumors with low risk of metastasis or mortality (5-year survival >90%), such as adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
• Pregnant or breastfeeding women.
• Any other condition that, in the opinion of the investigator, could lead to premature discontinuation of study treatment or compromise participant safety or compliance, including serious comorbidities (including psychiatric disorders requiring concomitant therapy), alcohol or substance abuse, or social/familial factors.