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The purpose of this study is to observe and evaluate the efficacy and safety of A sintilimab plus chemotherapy followed by definitive concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab plus chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab plus Chemotherapy | Drug | Sintilimab will be administered intravenously, a fixed dose of 200 mg. Paclitaxel 135mg/m2, carboplatin AUC=5. Once every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Control Rate | up to 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | up to 42 months | |
| Progression-free Survival | up to 42 months | |
| Overall Survival |
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Inclusion Criteria:
7. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1 8. Life expectancy ≥3 months 9. Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan Universtiy Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38356729 | Derived | Ai D, Hao S, Shen W, Wu Q, Zhang S, Chen Y, Liu Q, Deng J, Zhu H, Chen K, Mo M, Gu D, Liu Y, Zhang Z, Zhou G, Hu J, Zhang Z, Ye J, Zhao K. Induction sintilimab and chemotherapy followed by concurrent chemoradiotherapy for locally advanced esophageal cancer: a proof-of-concept, single-arm, multicenter, phase 2 trial. EClinicalMedicine. 2024 Feb 6;69:102471. doi: 10.1016/j.eclinm.2024.102471. eCollection 2024 Mar. |
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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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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| up to 42 months |
| 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 |