Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer

August 17, 2015 updated by: Biotech Pharmaceutical Co., Ltd.

Phase I Study of Nimotuzumab in Combination With Simultaneous Chemotherapy and Radiation for Patients With Locally Advanced Esophageal Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Esophageal Cancer
Drug: Nimotuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.
Time Frame: within study period
within study period

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the complete response rate、partial rate、disease responserate、disease control rate in the patients subject to treatment
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotech Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Xi-Chun Hu, Fu Dan University Cancer Hospital
  • Study Chair: Guo-Liang Jiang, Fu Dan University Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

July 16, 2009

First Submitted That Met QC Criteria

July 30, 2009

First Posted (Estimate)

July 31, 2009

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BT-ESO-T-0901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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