Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00950417
Recruitment Status : Completed
First Posted : July 31, 2009
Last Update Posted : August 19, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Advanced Esophageal Drug: Nimotuzumab Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Nimotuzumab in Combination With Simultaneous Chemotherapy and Radiation for Patients With Locally Advanced Esophageal Cancer
Study Start Date : July 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Esophageal Cancer Drug: Nimotuzumab

Primary Outcome Measures :
  1. Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated. [ Time Frame: within study period ]

Secondary Outcome Measures :
  1. To determine the complete response rate、partial rate、disease responserate、disease control rate in the patients subject to treatment [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00950417

China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Biotech Pharmaceutical Co., Ltd.
Principal Investigator: Xi-Chun Hu Fu Dan University Cancer Hospital
Study Chair: Guo-Liang Jiang Fu Dan University Cancer Hospital

Responsible Party: Biotech Pharmaceutical Co., Ltd. Identifier: NCT00950417     History of Changes
Other Study ID Numbers: BT-ESO-T-0901
First Posted: July 31, 2009    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: July 2009

Keywords provided by Biotech Pharmaceutical Co., Ltd.:
nimotuzumab esophageal chemo-radiotherapy

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases