Clinical Trial

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

Recruiting Phase 3
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Record status
This record was last updated November 14, 2024 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-06-16; most recent amendment 2024-11-12.
Status change: Not Yet Recruiting → Recruiting 2023-07-19
Trial Details
NCT Number NCT05919030
Lead Sponsor Renmin Hospital of Wuhan University
Conditions Esophageal Squamous Cell Carcinoma
Enrollment 155 participants
Start Date 2023-07-01
Primary Completion 2026-07-01 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2024-11-14