Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

March 3, 2022 updated by: Biotech Pharmaceutical Co., Ltd.

The Phase II of Nimotuzumab in Combination With Radiotherapy for 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 II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

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
      • Beijing, China
        • Cancer Institute & Hospital, Chinese Academy of Medical Sciences
      • Tianjin, China
        • Tianjin Medical University Cancer Institute and Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • The Affiliated tumour hosiptal of HARBIN Medical University
    • Hubei
      • Wuhan, Hubei, China
        • Wuhan Union Hospital
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital，Shandong University

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:

  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 .

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nimotuzumab group
Nimotuzumab+radiotherapy
Drug: Nimotuzumab
the nimotuzumab treatment; 200mg/w,weekly,5-6 weeks.
Radiation: Radiotherapy
the Radiotherapy treatment;95%PTV A dose of 50-60Gy will be administered in 25-30 fractions ( 2 Gy /fraction)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of AE(adverse event) or toxicity ( Both acute and chronic toxicity will be evaluated.)
Time Frame: 3 months
assement of advers event after using medication based TAAE evaluation form
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Complete response
Time Frame: 3 months
3 months
Partial response (PR)
Time Frame: 3 months
3 months
Stable disease (SD)
Time Frame: 3 months
3 months
Progressive disease (PD)
Time Frame: 3 months
3 months
Median survival time (MST)
Time Frame: 2 years
2 years
Overall survival (OS)
Time Frame: 1 year,2 years
1 year,2 years

Collaborators and Investigators

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

Sponsor

Biotech Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Lvhua Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

November 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 17, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimate)

October 30, 2015

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BT-IST-ESO-002

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.

Clinical Trials on Esophageal

Clinical Trials on Nimotuzumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe