Status:
COMPLETED
Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer
Lead Sponsor:
Biotech Pharmaceutical Co., Ltd.
Conditions:
Advanced Esophageal
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 b...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00950417
Start Date
July 1 2009
End Date
November 1 2012
Last Update
August 19 2015
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032