A Phase III Study of Nimotuzumab Plus Concurrent Chemoradiotherapy in Loco-regional Esophageal Squamous Cell Carcinoma

Inclusion Criteria:

1. Signed written informed consent prior to study entry
2. age：18-70 years
3. Histopathology confirmed primary esophageal squamous cell carcinoma, meet one of the following criteria (AJCC Staging System，2009，Seventh Edition):Cervical esophageal carcinoma(stage II-III);upper thoracic esophageal cancer or chest esophageal cancer that is unsuitable or refuse surgery (stage II-III)
4. The existence of measurable lesions (according to Response Evaluation Criteria in Solid Tumors 1.1)
5. Eastern Cooperative Oncology Group（ECOG）Performance status of 0-1
6. Possible semi-liquid diet
7. If there is a risk of pregnancy, male and female subjects must be effective contraception during treatment
8. Normal bone marrow reserve: neutrophil (ANC) count≥1500/mm3,platelet count≥100,000 /mm3, hemoglobin≥5.6mmol/L(9g/dL)
9. Normal renal function: serum creatinine≤1.5mg/dl and/or calculated creatinine clearance≥ 60ml/min
10. Normal hepatic function: bilirubin level≤1.5×ULN, alanine aminotransferase aspartate transaminase（ASAT）\& ALST≤1.5×ULN
11. Subjects tumor tissue available for the relevant biomarker detection

Exclusion Criteria:

1. Previous chest radiotherapy, systemic chemotherapy, and major esophageal surgery
2. Concurrent chronic systemic immune therapy, targeted therapy, anti-vascular endothelial growth factor（VEGF）therapy or EGFR-pathway targeting therapy not indicated in this study protocol
3. Multiple primary carcinomas of the esophagus
4. Pregnancy (confirmed by urine β-HCG) or lactation period
5. Uncontrolled diabetes, hypertension, and severe cardiac or pulmonary disease
6. There are obvious esophageal ulcers, chest and back more than moderate pain, symptoms of esophageal perforation
7. Unable to comprehend the study requirements or who are not likely to comply with the study requirements
8. Patients with distant metastasis
9. Patients with other malignant disease, except for curable non-melanoma skin cancer, cervical carcinoma in situ or malignant disease cure for≥5 years
10. Known grade 3 or 4 allergic reaction to any of the study treatment
11. Peripheral neuropathy \> grade 1
12. Participation in another clinical study within the past 30 days
13. Significant disease which, in the investigator's opinion, would exclude the patient from the study