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Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer

Primary Purpose

Advanced Esophageal

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Sponsored by
Biotech Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Esophageal focused on measuring nimotuzumab esophageal chemo-radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fudan University Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Esophageal Cancer

Arm Description

Outcomes

Primary Outcome Measures

Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.

Secondary Outcome Measures

To determine the complete response rate、partial rate、disease responserate、disease control rate in the patients subject to treatment

Full Information

First Posted
July 16, 2009
Last Updated
August 17, 2015
Sponsor
Biotech Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00950417
Brief Title
Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer
Official Title
Phase I Study of Nimotuzumab in Combination With Simultaneous Chemotherapy and Radiation for Patients With Locally Advanced Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotech Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Esophageal
Keywords
nimotuzumab esophageal chemo-radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Esophageal Cancer
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Primary Outcome Measure Information:
Title
Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.
Time Frame
within study period
Secondary Outcome Measure Information:
Title
To determine the complete response rate、partial rate、disease responserate、disease control rate in the patients subject to treatment
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xi-Chun Hu
Organizational Affiliation
Fu Dan University Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guo-Liang Jiang
Organizational Affiliation
Fu Dan University Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

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Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer

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