Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer

NCT ID: NCT00950417

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-11-30

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 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.

Conditions

Advanced Esophageal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Esophageal Cancer

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

Interventions

Nimotuzumab

Intervention Type: DRUG

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotech Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xi-Chun Hu

Role: PRINCIPAL_INVESTIGATOR

Fu Dan University Cancer Hospital

Guo-Liang Jiang

Role: STUDY_CHAIR

Fu Dan University Cancer Hospital

Locations

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

BT-ESO-T-0901

Identifier Type: -

Identifier Source: org_study_id