Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer
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Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase I study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemo-radiotherapy in patients with locally advanced esophageal cancer tumours.
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Informed consent form signed before performing any of the study's specific procedures.
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 technique.
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 immuno-deficiency
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 aphthosis, 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