drugset / Trial / NCT05919030

A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma

NCT05919030

Phase 3 Recruiting 155 enrolled Renmin Hospital of Wuhan University
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a multicentre, randomised, parallel-controlled, open-label, 3 phase clinical trial. The subjects were untreated, unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma with low PD-L1 expression. Patients were randomly assigned to receive chemoradiation or chemotherapy in combination with Tislelizumab at a ratio of 1: 1. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We hypothesized that in advanced esophageal squamous cell carcinoma patients with low PD-L1 expression, chemoradiation versus chemotherapy in combination with Tislelizumab will significantly improve PFS.

Timeline

Start
2023-07-01
Primary completion
2026-07-01
Completion
2027-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 25 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Paclitaxel Small molecule 75 mg/m2 Intravenous
Subject Paclitaxel Small molecule 220 mg/m2 Intravenous
Background Tislelizumab Monoclonal antibody 200 mg Intravenous