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Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

Primary Purpose

Esophageal

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Radiotherapy
Sponsored by
Biotech Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  1. pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis.
  2. with the measureable lesion of the newly diagnosed the esophageal carcinoma.
  3. age 18-75 years old
  4. ECOG≤2
  5. Expect survival date ≥3 months
  6. without serious diseases of important organs
  7. signature in the inform consent.

Exclusion Criteria:

  1. pregnant or breast-feeding women or using a prohibited contraceptive method.
  2. with psychiatric diseases.
  3. with serious diseases or uncontrolled infection.
  4. with history of other tumors.
  5. participation other clinical trials within 1 month prior to inclusion in the trial.
  6. not the first antitumor treatment .

Sites / Locations

  • The Affiliated tumour hosiptal of HARBIN Medical University
  • Wuhan Union Hospital
  • Qilu Hospital,Shandong University
  • Cancer Institute & Hospital, Chinese Academy of Medical Sciences
  • Tianjin Medical University Cancer Institute and Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nimotuzumab group

Arm Description

Nimotuzumab+radiotherapy

Outcomes

Primary Outcome Measures

The rate of AE(adverse event) or toxicity ( Both acute and chronic toxicity will be evaluated.)
assement of advers event after using medication based TAAE evaluation form

Secondary Outcome Measures

Complete response
Partial response (PR)
Stable disease (SD)
Progressive disease (PD)
Median survival time (MST)
Overall survival (OS)

Full Information

First Posted
August 17, 2015
Last Updated
March 3, 2022
Sponsor
Biotech Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02591784
Brief Title
Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer
Official Title
The Phase II of Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

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 II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.
Detailed Description
Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nimotuzumab group
Arm Type
Experimental
Arm Description
Nimotuzumab+radiotherapy
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
the nimotuzumab treatment; 200mg/w,weekly,5-6 weeks.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
the Radiotherapy treatment;95%PTV A dose of 50-60Gy will be administered in 25-30 fractions ( 2 Gy /fraction)
Primary Outcome Measure Information:
Title
The rate of AE(adverse event) or toxicity ( Both acute and chronic toxicity will be evaluated.)
Description
assement of advers event after using medication based TAAE evaluation form
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Complete response
Time Frame
3 months
Title
Partial response (PR)
Time Frame
3 months
Title
Stable disease (SD)
Time Frame
3 months
Title
Progressive disease (PD)
Time Frame
3 months
Title
Median survival time (MST)
Time Frame
2 years
Title
Overall survival (OS)
Time Frame
1 year,2 years

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: pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis. with the measureable lesion of the newly diagnosed the esophageal carcinoma. age 18-75 years old ECOG≤2 Expect survival date ≥3 months without serious diseases of important organs signature in the inform consent. Exclusion Criteria: pregnant or breast-feeding women or using a prohibited contraceptive method. with psychiatric diseases. with serious diseases or uncontrolled infection. with history of other tumors. participation other clinical trials within 1 month prior to inclusion in the trial. not the first antitumor treatment .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lvhua Wang
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated tumour hosiptal of HARBIN Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Qilu Hospital,Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
Country
China

12. IPD Sharing Statement

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Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

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