A Phase III Study of First-line Anlotinib Combined With Benmelstobart in Patients With Advanced Esophageal Squamous Cell Carcinoma

Exclusion criteria

• ✕. New York Heart Association (NYHA) Class II or greater heart failure or left ventricular ejection fraction (LVEF) \<50% by echocardiography;
• ✕. History of clinically significant ventricular arrhythmia (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or arrhythmia requiring continuous antiarrhythmic medication;
• ✕. Unstable angina pectoris;
• ✕. Myocardial infarction within 12 months;
• ✕. Fridericia-corrected QT interval (QTcF) \>450 msec for males or \>470 msec for females (if abnormal, three consecutive measurements ≥2 minutes apart, use average);
• ✕. Congenital long QT syndrome or family history;
• ✕. History of deep vein thrombosis, pulmonary embolism, or other serious thromboembolism within 3 months prior to randomization (implanted port or catheter-related thrombosis, or superficial venous thrombosis not considered "serious");
• ✕. Current use or recent use (within 7 days prior to study treatment) of aspirin (\>325 mg/day), dipyridamole, ticlopidine, clopidogrel, or cilostazol; (14) Active or uncontrolled severe infection (≥CTCAE Grade 2); (15) Renal failure requiring hemodialysis or peritoneal dialysis; (16) History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency disorders; (17) Use of immunosuppressants or systemic or absorbable topical corticosteroids for immunosuppressive purposes within 7 days prior to first dose (except prednisone ≤10 mg daily or equivalent); (18) Epilepsy requiring treatment; (19) Tumor-related symptoms and treatment: