Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
A Randomized, Double-blind, Parallel-controlled, Multicenter Phase III Clinical Study
This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of carrelizumab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy in the treatment of patients with inoperably advanced esophageal cancer, and to explore the relationship between PD-L1 expression and efficacy in tumor tissues. Experimental group: carrelizumab in combination with concurrent chemoradiotherapy PD-1: carrelizumab: 200 mg/3W Chemotherapy: Paclitaxel: 50 mg/m2/W Cisplatin: 25mg/m2/W Radiotherapy: 50.4 Gy / 28 f Chemotherapy drugs are used for 5 cycles, and carrelibizumab is used for up to 24 months until PD or is intolerable Control group: placebo-resistant in combination with chemoradiotherapy placebo: 200 mg/3 W Chemotherapy: Paclitaxel: 50 mg/m2/W Cisplatin: 25mg/m2/W Radiotherapy: 50.4 Gy / 28 f Chemotherapy drugs are used for 5 cycles, and carrelibizumab is used for up to 24 months until PD or is intolerable
Experimental group: carrelizumab in combination with concurrent chemoradiotherapy PD-1: carrelizumab: 200 mg/3W Chemotherapy: Paclitaxel: 50 mg/m2/W Cisplatin: 25mg/m2/W Radiotherapy: 50.4 Gy / 28 f Chemotherapy drugs are used for 5 cycles, and carrelibizumab is used for up to 24 months until PD or is intolerable Control group: placebo-resistant in combination with chemoradiotherapy placebo: 200 mg/3 W Chemotherapy: Paclitaxel: 50 mg/m2/W Cisplatin: 25mg/m2/W Radiotherapy: 50.4 Gy / 28 f Chemotherapy drugs are used for 5 cycles, and carrelibizumab is used for up to 24 months until PD or is intolerable ;
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