Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer
Conditions
Advanced Esophageal
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
nimotuzumab esophageal chemo-radiotherapy
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Nimotuzumab and chemoradiation
Type: Drug
Overall Status
Recruiting
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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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 Criteria:

- 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
Location
Fudan University Cancer Hospital
Shanghai, Shanghai, China
Status: Recruiting
Contact: Xichun Hu
Start Date
July 2009
Completion Date
December 2010
Sponsors
Biotech Pharmaceutical Co., Ltd.
Source
Biotech Pharmaceutical Co., Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page