drugset / Trial / NCT07446335

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

NCT07446335

Phase 3 Not yet recruiting 578 enrolled The First Affiliated Hospital of Zhengzhou University
RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2026-04
Primary completion
2028-12
Completion
2029-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Benmelstobart Monoclonal antibody 1200 mg Intravenous
Subject Catequentinib Small molecule 12 mg Oral
Comparator Cisplatin Other / unclassified 60 mg/m2 Intravenous
Comparator Cisplatin Other / unclassified 75 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 150 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 175 mg/m2 Intravenous
Comparator Toripalimab Monoclonal antibody 240 mg Intravenous
Comparator fluorouracil Small molecule 700 mg/m2 Intravenous
Comparator fluorouracil Small molecule 850 mg/m2 Intravenous