NCT02591784

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2008

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
Last Updated

March 17, 2022

Status Verified

August 1, 2015

Enrollment Period

3.1 years

First QC Date

August 17, 2015

Last Update Submit

March 3, 2022

Conditions

Esophageal

Keywords

nimotuzumab esophageal radiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (6)

  • Complete response

    3 months

  • Partial response (PR)

    3 months

  • Stable disease (SD)

    3 months

  • Progressive disease (PD)

    3 months

  • Median survival time (MST)

    2 years

  • +1 more secondary outcomes

Study Arms (1)

Nimotuzumab group

EXPERIMENTAL

Nimotuzumab+radiotherapy

Drug: NimotuzumabRadiation: Radiotherapy

Interventions

NimotuzumabDRUG

the nimotuzumab treatment; 200mg/w,weekly,5-6 weeks.

Nimotuzumab group
RadiotherapyRADIATION

the Radiotherapy treatment;95%PTV A dose of 50-60Gy will be administered in 25-30 fractions ( 2 Gy /fraction)

Nimotuzumab group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • not the first antitumor treatment .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Affiliated tumour hosiptal of HARBIN Medical University

Harbin, Heilongjiang, China

Location

Wuhan Union Hospital

Wuhan, Hubei, China

Location

Qilu Hospital,Shandong University

Jinan, Shandong, China

Location

Cancer Institute & Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

MeSH Terms

Interventions

nimotuzumabRadiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Lvhua Wang

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2015

First Posted

October 30, 2015

Study Start

November 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 17, 2022

Record last verified: 2015-08

Locations

CN(5)