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The purpose of this study is to investigate the efficacy and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with a PD-1/CTLA-4 bispecific antibody (Cadonilimab) in combination with platinum-containing chemotherapy (Paclitaxel Polymeric Micelles for Injection combined with Cisplatin). Includes pathologic complete remission rates (pCR rates) after 2-4 cycles of Cadonilimab combination chemotherapy. The objective remission rate (ORR), major pathologic remission rate (MPR), R0 resection rate and 2-year overall survival (OS) and progression-free survival (OS) rates, and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with Cadonilimab combined with chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel Polymeric Micelles for Injection and Cisplatin Combined with Cadonilimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel Polymeric Micelles for Injection and Cisplatin combined with Cadonilimab | Drug | Paclitaxel Polymeric Micelles for Injection:Cycle 1: 230mg/m2, IV ≥3 hours; Cycles 2-4: If the patient has a neutrophil nadir ≥1.0 x 109/L along with a platelet nadir ≥80 x 109/L after Cycle 1 dosing and has not experienced grade II-IV non-hematologic toxicity, then give 260mg/m2, IV ≥3 hours, d1, q3w; Cisplatin: 25mg/m2/d x d1-3, IV drip, q3w; Cadonilimab: 10mg/kg, IV drip, d3, q3w; |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) rates | evaluate pathological complete response rate of primary tumor and locally metastatic lymph nodes after 2-4 cycles of neoadjuvant therapy. | From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Rate of Effectiveness (ORR) | the proportion of patients who achieve PR or CR | From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks. |
| R0 Removal Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Sun | Contact | 13914704178 | sunj@njmu.edu.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
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Paclitaxel Polymeric Micelles for Injection and Cisplatin combined with Cadonilimab
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|
Rate of microscopically margin-negative resection
| From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks. |
| 2-year overall survival rate | 2-year overall survival rate | 2 years |
| 2-year disease free survival rate | 2-year disease free survival rate | 2 years |
| major pathological response (MPR) | From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks. |
| 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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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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