A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma
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
About This Trial
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Intensity-modulated radiotherapy (IMRT)
Esophageal primary tumor: 39.6Gy/2.2Gy Bone metastasis: 30Gy/3Gy Lung, liver, brain metastases, metastatic lymph nodes: 45Gy/3Gy
Tislelizumab
200 mg IV Q3W
Cisplatin
During concurrent radiation therapy: 25 mg/m² IV QW During consolidation therapy: 75 mg/m² IV Q3W
Nab paclitaxel
During concurrent radiation therapy: 75 mg/m² IV QW During consolidation therapy: 220 mg/m² IV Q3W