Esophageal Squamous Cell Carcinoma Resectable Clinical Trial
Official title:
A Prospective, Single Arm, Multicenter, Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma
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
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | September 2017 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
| Lead Sponsor | Collaborator |
|---|---|
| Zhejiang Cancer Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pathology complete remission rate | Pathology complete remission rate is the primary outcome measure. | 1 year | No |
| Secondary | R0 resection rate | 1 year | No | |
| Secondary | objective response rate | Objective response rate of neoadjuvant chemotherapy will be assessed. | 1 year | No |
| Secondary | overall survival | 5 years | No | |
| Secondary | tolerability and safety | number of adverse events such as leucopenia ,rash,diarrhea and so on | 2 years | Yes |
| Secondary | Quality of life | Quality of life of patients will be evaluated during and after therapy. | 5 years | No |