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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Zhengzhou University

About this trial

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

Eligibility criteria

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • anlotinib combined with benmelstobart
  • Toripalimab Combined with Chemotherapy

Treatment groups

578 Participants
are divided into 2 treatment groups