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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: cadonilizumab combined with neoadjuvant radiochemotherapy | Experimental | Subjects randomized in Arm 1 will be treated with cadonilizumab plus neoadjuvant radiochemotherapy before surgery. |
|
| Arm 2: neoadjuvant radiochemotherapy | Placebo Comparator | Subjects randomized in Arm 2 will be treated with neoadjuvant radiochemotherapy before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cadonilizumab combined with neoadjuvant radiochemotherapy | Combination Product | Subjects randomized to experimental arm will be treated with PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy before surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| pCR | pathological complete response | perioperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fuwei Wang | Contact | 0086-037166278517 | wanxbo@zzu.edu.cn | |
| Xiangbo Wan | Contact | 0086-037166271152 | wanxbo@zzu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiangbo Wan | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450000 | China |
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|
| neoadjuvant radiochemotherapy | Combination Product | Subjects in the arm 2, the control arm, will be treated with neoadjuvant radiochemotherapy. |
|
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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