Phase I Study of Nimotuzumab in Combination With Simultaneous Chemotherapy and Radiation for Patients With Locally Advanced Esophageal Cancer
- Informed consent form signed before performing any of the study's specific
- ECOG performance status 0-2.
- Age > 18 and < 75.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria,
greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT)
scan and MRI or greater than or equal to 2 cm by other ordinary radiographic
- Histologically confirmed diagnosis of locally advanced esophageal.
- Life expectancy of more than 3 months.
- Use of an effective contraceptive method for patients of both sexes when there is a
risk of conception and/or pregnancy.
- No serious blood producing,abnormal function of heart,lung, liver, or kidney or
- Neutrophils ≥3×109/L, platelet count≥100×109/L and haemoglobin≥9g/dL ,Creatinine ≤
1.5 x NUL
- Previous radiotherapy or chemotherapy
- Pregnant or breast-feeding women
- Drug abuse, unhealthy drug/alcohol addiction,or virus (HIV) infection
- Evidence of distant metastasis
- Participation in other clinical trials
- Patients with aphagosis, complete obstruction, fistula or deep peptic ulcer in the
esophagus, or haematemesis
- Uncontrolled psychiatric disease or seizure
- Patients not fit for the clinical trial judged by the investigators