RecruitingPhase 2NCT07016724

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

Sponsor

The First Affiliated Hospital of Zhengzhou University

Enrollment

208 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the addition of an immunotherapy drug (cadonilizumab) to standard chemoradiation therapy given before surgery in patients with locally advanced esophageal squamous cell cancer — a type of cancer in the food pipe — to see if it can shrink tumors more effectively. **You may be eligible if...** - You have been diagnosed with esophageal squamous cell cancer at a locally advanced stage (not yet spread to distant organs) - You have not received any previous cancer treatment - You are in good general health (ECOG 0 or 1) - You are being considered for surgery after neoadjuvant (pre-surgery) treatment - Your expected survival is more than 6 months and your organ function is adequate **You may NOT be eligible if...** - You have been diagnosed with another cancer in the past 5 years - You have a tendency to bleed - You have already received any cancer-related treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTcadonilizumab 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_PRODUCTneoadjuvant 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

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NCT07016724

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