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To verify the role of nab-paclitaxel in neoadjuvant therapy for esophageal squamous cell carcinoma, the investigators designed a prospective, randomized, controlled , multicente phase II trial, to investigate the efficacy and safety of nab-paclitaxel combined with cisplatin as neoadjuvant therapy followed by surgery versus surgery alone for esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neo-adjuvant chemotherapy group | Experimental | cisplatin and nab-paclitaxel: Nab-paclitaxel, 125mg/m(2), d1,d8, Cisplatin, 75mg/m(2), d1, 3 week, 2 cycles. Surgery: 4-6weeks after Neo-adjuvant chemotherapy |
|
| Surgery alone | Active Comparator | Surgery alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab-paclitaxel and Cisplatin | Drug | Nab-paclitaxel,125mg/m(2), d1,d8, Cisplatin,75mg/m(2), d1, 3 week, 2 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival,From date of randomization until death due to any cause | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS rate | Overall survival rate | 1 year,3years,5years |
| DFS rate | Disease free survival rate | 1 year,3years,5years |
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Inclusion Criteria:
Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function:Total bilirubin ≤ 1.5x ULN;AST and ALT) ≤ 2.5x ULN Renal function:Cr ≤ 1.5x ULN,Ccr ≥ 55 ml/min Coagulation function:INR≤1.5×ULN, PT≤1.5ULN, APTT within the normal range
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junfeng Liu, PhD | Contact | 13931152296 | liujf@hbmu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jun Feng Liu | Recruiting | Shijiazhuang | Hebei | 050011 | China |
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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 |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D002945 | Cisplatin |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| surgery | Procedure | surgery |
|
| R0 resection rate | R0 resection rate | within 4 weeks following the operation |
| Down-staging rate | Down-staging rate | within 6 weeks following the last dose of chemotherapy |
| Rate of Operative Complications | within 4 weeks following the operation |
| Rate of Adverse Event | Incidence of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 | up to 6 weeks after the last dose of chemotherapy |
| 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 |