NCT06048926

Carrelizumab Combined With Concurrent Radiotherapy and Chemotherapy for Unresectable Esophageal Squamous Cell Carcinoma

A Randomized, Double-blind, Parallel-controlled, Multicenter Phase III Clinical Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Carrelizumab	200 mg/time, iv, Q3W
DRUG	Paclitaxel injection	50mg/m2,iv, D1, 8, 15, 22, 29, once a week, a total of 5 times
DRUG	Cisplatin	25mg/m2，iv， D1、8、15、22、29，once a week, a total of 5 times
RADIATION	Concurrent chemoradiotherapy	Radiotherapy was given simultaneously at the time of the first dose, and the total dose of radiotherapy was 50.4 Gy, which was completed in 28 divided doses of 1.8 Gy each time, 5 times a week.

Timeline

• Start date: 2022-07-30
• Primary completion: 2025-07-30
• Completion: 2028-07-30
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: China