Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer

Biotech Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Advanced Esophageal

Treatments: Drug: Nimotuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00950417

BT-ESO-T-0901

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Esophageal Cancer

Experimental group

Treatment:

Drug: Nimotuzumab