Neoadjuvant Radiochemotherapy Combined With Cadonilizumab for Local Advanced Esophageal Squamous Cell Cancer
The First Affiliated Hospital of Zhengzhou University
208 participants
Aug 15, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- diagnosed with esophageal squamous cell cancer;
- staged with cT1N+M0/cT2-3N0-3M0;
- experienced no cancer-related treatment;
- ECOG 0-1;
- Expected survival more than 6 months;
- aimed at neoadjuvant therapy for surger;
- have adquate organ function.
Exclusion Criteria3
- diagnosed with other types of cancer during last five years;
- have a tendency to bleed;
- accepted any type of cancer-related therapy.
Interventions
Subjects randomized to experimental arm will be treated with PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy before surgery.
Subjects in the arm 2, the control arm, will be treated with neoadjuvant radiochemotherapy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07016724