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| Name | Class |
|---|---|
| Jiangsu Simcere Pharmaceutical Co., Ltd. | INDUSTRY |
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This single center, prospective, single arm clinical study aims to evaluate the clinical efficacy and safety of Envafolimab combined with albumin bound paclitaxel and carboplatin as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Envafolimab+Chemotherapy Group(EC Group) | Experimental | Envafolimab: 150mg, subcutaneous injection, administered on days 1, 8, and 15, treated for 3 weeks, followed by a 1-week rest period; Albumin bound paclitaxel: administered on days 1, 8, and 15, 100 mg/m2, IV , treated for 3 weeks, followed by a 1-week rest period; Carboplatin: administered on days 1, AUC 5, treated for 3 weeks, followed by a 1-week rest period. All patients will receive treatment with Envafolimab combined with albumin bound paclitaxel and carboplatin for three weeks, followed by one week of rest and a 28 day treatment cycle, for a total of two cycles. Then, the tumor condition of the patients will be evaluated to determine whether surgical treatment is feasible. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy (Albumin bound paclitaxel and Carboplatin) | Drug | Albumin bound paclitaxel: administered on days 1, 8, and 15, 100 mg/m2, IV , treated for 3 weeks, followed by a 1-week rest period; Carboplatin: administered on days 1, AUC 5, treated for 3 weeks, followed by a 1-week rest period. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) rate | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | From enrollment to the end of treatment at 10 weeks | |
| Major pathological response rate | From enrollment to the end of treatment at 8 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Di Ge, MD | Contact | 86-18202188606 | gedi@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ORR |
Objective response rate |
| From enrollment to the end of Cycle 2 (each cycle is 28 days) |
| 3y-RFS rate | 3-year recurrence free survival rate | From enrollment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 36 months |
| 3y-OS rate | 3-year Overall survival rate | From enrollment until the date of death from any cause, assessed up to 36 months |
| 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 |
|---|---|
| D016190 | Carboplatin |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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