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This study is aimed to evaluate the efficacy and safety of different doses of radiotherapy combined with sintilimab in locally advanced esophageal squamous cell carcinoma.
This study was designed as a two cohorts, phase II trial. Subjects will receive different doses of radiotherapy combined with sintilimab. The primary endpoint is progression-free survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | dose 1 of radiotherapy+sintilimab |
|
| Group B | Experimental | dose 2 of radiotherapy+sintilimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chemoradiotherapy (CRT)+sintilimab 1 | Drug | radiotherapy (50.4Gy/1.8Gy/28f)+chemotherapy (paclitaxel 150mg/m2 D1+cisplatin 25mg/m2 D1-3,Q3W)+Sintilimab (200mg, iv, D1, Q3W) Consolidation therapy: Sintilimab: 200mg, iv, D1, Q3W |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | the time from random assignment in a clinical trial to disease progression or death from any cause | 1 years |
| 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 |
| Objective Response Rate | the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiancheng Li | Contact | 86-13906900190 | jianchengli6@126.com |
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| CRT+sintilimab 2 | Drug | radiotherapy (60Gy/2Gy/30f)+chemotherapy (paclitaxel 150mg/m2 D1+cisplatin 25mg/m2 D1-3,Q3W)+Sintilimab (200mg, iv, D1, Q3W) Consolidation therapy: Sintilimab: 200mg, iv, D1, Q3W |
|
| 3 months after therapy |
| 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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