drugset / Trial / NCT06061146

Summary

This study was conducted in elderly (≥70 years old) patients with locally advanced esophageal squamous cell carcinoma. Aim to find the difference in efficacy and safety between tirilizumab combined with concurrent chemoradiation and standard concurrent chemoradiation. Concurrent chemoradiation is the standard treatment for elderly esophageal cancer. Tirelizumab is the first-line and second-line standard treatment for advanced esophageal squamous carcinoma. However, the effect of tirilizumab combined with concurrent chemoradiation for elder with locally advanced esophageal squamous cell carcinoma is unkown. In the study, the investigators plan to enroll 136 elderly subjects with locally advanced esophageal cancer from five hospitals in China. The enrolled patients will be randomly divided into two groups: tirilizumab combined with concurrent chemoradiation group (Tislelizumab + radiotherapy + tigio) and concurrent chemoradiation group (radiotherapy + tigio). The treatment efficiency and safety will be evaluated.

Timeline

Start
2023-10-05
Primary completion
2024-10-01
Completion
2026-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous
Background S-1 Small molecule 40 mg Oral
Background S-1 Small molecule 60 mg Oral

Indications