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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGPathology complete remission rate
Pathology complete remission rate is the primary outcome measure.
Time frame: 1 year
R0 resection rate
Time frame: 1 year
objective response rate
Objective response rate of neoadjuvant chemotherapy will be assessed.
Time frame: 1 year
overall survival
Time frame: 5 years
tolerability and safety
number of adverse events such as leucopenia ,rash,diarrhea and so on
Time frame: 2 years
Quality of life
Quality of life of patients will be evaluated during and after therapy.
Time frame: 5 years
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