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This study is aimed to evaluate the efficacy and safety of short-course radiotherapy combined with sintilimab in neoadjuvant treatment of stage III, locally advanced esophageal squamous cell carcinoma.
This study was designed as a single arm, phase II trial. Subjects will receive short-course radiotherapy combined with sintilimab as neoadjuvant therapy of stage III, locally advanced esophageal squamous cell carcinoma. The primary endpoint is pathologic complete response(pCR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| short-course radiotherapy+sintilimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sintilimab,programmed death 1 monoclonal antibody | Drug | short-course radiotherapy +sintilimab (200mg, iv, D1, Q3W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response | Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell | 4 weeks after surgery |
| Incidence rate of adverse events | The ratio of the number of cases with adverse events to the total number of cases available for evaluation. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | the time from randomization to death | 3 years |
| Disease-free survival | the time from treatment until the recurrence of disease (or death) after undergoing curative-intent treatment |
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Inclusion Criteria:
18 years old and ≤75 years old
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiancheng Li | Contact | 86-13906900190 | jianchengli6@126.com |
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| 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 |
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| 3 years |
| 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 |