Spots Global Cancer Trial Database for A Study of Chemoradiation in Combination With Tislelizumab as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

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Trial Identification

Brief Title: A Study of Chemoradiation in Combination With Tislelizumab as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

Official Title: Chemoradiation Versus Chemotherapy in Combination With Tislelizumab as First Line Treatment for Advanced Esophageal Squamous Cell Carcinoma With Low PD-L1 Expression (RENMIN-236): Multicentre, Randomised, Phase 3 Trial

Study ID: NCT05919030

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Intensity-modulated radiotherapy (IMRT)

Tislelizumab

Cisplatin

Nab paclitaxel

Study Description

Brief 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.

Detailed Description: