A Randomized, Open-Label, Parallel-Controlled, Multicenter Phase III Clinical Trial to Evaluate the Safety and Efficacy of Anlotinib Hydrochloride Combined with Benmelstobart versus Toripalimab Combined with Chemotherapy as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma Harboring Specific Gene Mutations
Hemoglobin ≥90 g/L;
Absolute neutrophil count (ANC) ≥1.5 × 10^9/L;
Platelets ≥75 × 10^9/L;
Total bilirubin ≤1.5 × upper limit of normal (ULN);
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;
Parallel
anlotinib combined with benmelstobart
DrugBenmelstobart injection 1200 mg will be diluted in 250 mL normal saline (0.9% sodium chloride) and administered via intravenous infusion over 60 ± 10 minutes on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or a maximum of 24 months. Anlotinib hydrochloride capsules 12 mg will be administered orally once daily before breakfast at approximately the same time each day on a schedule of 2 weeks on and 1 week off in 21-day cycles until disease progression or unacceptable toxicity.
Toripalimab Combined with Chemotherapy
DrugInduction Phase (maximum 6 cycles):Toripalimab injection 240 mg will be administered intravenously over 60 minutes on Day 1 of each 21-day cycle after dilution in 100 mL normal saline (0.9% sodium chloride). Chemotherapy regimen will be determined prior to randomization based on individual patient characteristics. Patients will receive one of the following chemotherapy regimens per local treatment standards: Cisplatin 60-75 mg/m² intravenously on Day 1 plus paclitaxel 150-175 mg/m² intravenously over \>3 hours, both administered every 3 weeks; or cisplatin 60-75 mg/m² intravenously on Day 1 plus fluorouracil 700-850 mg/m² daily by continuous intravenous infusion over 24 hours on Days 1-5, repeated every 3 weeks. Maintenance Phase :Toripalimab injection 240 mg will be administered intravenously over 60 minutes on Day 1 of each 21-day cycle after dilution in 100 mL normal saline (0.9% sodium chloride).
PFS
The time from randomization to the first occurrence of disease progression or death due to any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1.
OS
The time from randomization to death due to any cause.
ORR
The percentage of subjects with complete response (CR) or partial response (PR) as determined by the investigator according to RECIST 1.1.
DCR
The percentage of subjects with complete response (CR), partial response (PR), or disease stabilization (SD) for ≥6 weeks as determined by the investigator according to RECIST 1.1.
DOR
The time from the first documented confirmed objective response to disease progression or death due to any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1.
AE
The incidence and severity of adverse events, with severity graded according to the NCI CTCAE v5.0 scale.
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