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ENROLLING BY INVITATION
NCT06048926
NA

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

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-07-30

Completion Date

2028-07-30

Last Updated

2023-09-21

Healthy Volunteers

No

Interventions

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.

Locations (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China