NCT07016724

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-15
• Primary completion: 2026-08-31
• Completion: 2027-08-31
• First posted: 2025-06-12
• Last updated: 2025-06-12

Locations

1 site across 1 country: China