Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma

Study Overview
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Brief Summary
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A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone for esophageal cancer. And neoadjuvant chemotherapy may improve overall survival after surgical resection. Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and toxicity

Detailed Description
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A surgical resection is currently the preferred treatment for esophageal cancer if the tumor is considered to be resectable without evidence of distant metastases. A higher percentage of radical resection is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone. The neoadjuvant chemotherapy may improve overall survival. Neoadjuvant chemotherapy with administrations of paclitaxel combined with cisplatin or carboplatin has shown effectively. Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). The clinical phase I study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in patients with local advanced esophageal squamous cell carcinoma has shown the safety and the potential efficacy of Nimotuzumab. The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemotherapy in patients with resectable Esophageal Squamous Cell Carcinoma, and to further investigate its side-effect and toxicity.

Official Title
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A Prospective, Single Arm, Multicenter, Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma

Conditions
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Esophageal Squamous Cell Carcinoma Resectable

Intervention / Treatment
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* Drug: Nimotuzumab combined with paclitaxel and cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytologic diagnosis of Esophageal squamous cell carcinoma ECOG performance status 0-2 Age:18-70 years Joined the study voluntarily and signed informed consent form Patients must not have received any prior anticancer therapy Resectable disease, Stage IIA-IIIC, T2N0M0-T3N1M0（AJCC 2009） Target lesions can be measured according to RECIST criteria No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN Use of an effective contraceptive for adults to prevent pregnancy Life expectancy of more than 3 months Exclusion Criteria: Not suitable to surgery cervical Esophageal Carcinoma(distance of incisor tooth<19cm) early Esophageal Carcinoma(Stage I) complete esophageal obstruction，Esophageal perforation or hematemesis other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior 11、 History of serious allergic or castor oil allergy 12、 Patients who are not suitable to participate in the trial according to researchers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nimotuzumab plus chemotherapy<br> | Drug: Nimotuzumab combined with paclitaxel and cisplatin<br>* Nimotuzumab: 200mg, IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36). Cisplatin: 75mg/m2,IV on days 1，22 paclitaxel: 90mg/m2, IV on days 1,8,22,29. patients will receive radical operation 4-6 weeks after Neoadjuvant therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathology complete remission rate | Pathology complete remission rate is the primary outcome measure. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate |  | 1 year | 
| objective response rate | Objective response rate of neoadjuvant chemotherapy will be assessed. | 1 year | 
| overall survival |  | 5 years | 
| tolerability and safety | number of adverse events such as leucopenia ,rash,diarrhea and so on | 2 years | 
| Quality of life | Quality of life of patients will be evaluated during and after therapy. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Squamous Cell Carcinoma, neoadjuvant therapy, Nimotuzumab