Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer

Phase 1

Completed

• Conditions: Advanced Esophageal
• Interventions: Drug: Nimotuzumab

• Registration Number: NCT00950417
• Lead Sponsor: Biotech Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-07
• Study Start: 2009-07
• Study First Submitted: 2009-07-16
• Study First Submitted QC: 2009-07-30
• Study First Posted: 2009-07-31
• Primary Completion: 2010-07
• Study Completion: 2012-11
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Esophageal Cancer	Nimotuzumab	-

Primary Outcome Measures

Name	Time	Method
Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.	within study period

Secondary Outcome Measures

Name	Time	Method
To determine the complete response rate、partial rate、disease responserate、disease control rate in the patients subject to treatment	6 months

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China