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RECRUITING
NCT07016724
PHASE2

Neoadjuvant Radiochemotherapy Combined With Cadonilizumab for Local Advanced Esophageal Squamous Cell Cancer

Sponsor: The First Affiliated Hospital of Zhengzhou University

View on ClinicalTrials.gov

Summary

Esophageal squamous cell cancer (ESCC) has a high incidence in China. Although the fast development of immune check point inhibitors (ICIs), the rate of pCR is limited with the mode of ICIs combined with neoadjuvant radiochemotherapy. The rate of pCR under ICIs combined with neoadjuvant radiochemotherapy was reported around 50%, which means more than half of those patients could not obtain pCR in reality. In order to explore a more effective mode of neoadjuvant therapy for ESCC, we designed this study to evaluate the effect of PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy in local advanced ESCC.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

208

Start Date

2024-08-15

Completion Date

2027-08-31

Last Updated

2025-06-12

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

cadonilizumab combined with neoadjuvant radiochemotherapy

Subjects randomized to experimental arm will be treated with PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy before surgery.

COMBINATION_PRODUCT

neoadjuvant radiochemotherapy

Subjects in the arm 2, the control arm, will be treated with neoadjuvant radiochemotherapy.

Locations (1)

the First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China