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CompletedNCT02591784Updated Mar 17, 2022

Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

A Phase 2 interventional study of Nimotuzumab and Radiotherapy in Esophageal, sponsored by Biotech Pharmaceutical Co., Ltd.. Completed at 5 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-17.

Sponsored by Biotech Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Esophageal

Keywords

  • nimotuzumab esophageal radiotherapy
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 42 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Biotech Pharmaceutical Co., Ltd. is the lead sponsor of 31 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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 .
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Nimotuzumab group

    Nimotuzumab+radiotherapy

    Drug: Nimotuzumab · Radiation: Radiotherapy

Interventions

  • DrugNimotuzumab

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

  • RadiationRadiotherapy

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

06

What researchers measure

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

    Time frame: 3 months

Secondary outcomes

  1. Complete response

    Time frame: 3 months

  2. Partial response (PR)

    Time frame: 3 months

  3. Stable disease (SD)

    Time frame: 3 months

  4. Progressive disease (PD)

    Time frame: 3 months

  5. Median survival time (MST)

    Time frame: 2 years

  6. Overall survival (OS)

    Time frame: 1 year,2 years

07

Study locations

5 sites
  • The Affiliated tumour hosiptal of HARBIN Medical University
    Harbin, Heilongjiang, China
  • Wuhan Union Hospital
    Wuhan, Hubei, China
  • Qilu Hospital,Shandong University
    Jinan, Shandong, China
  • Cancer Institute & Hospital, Chinese Academy of Medical Sciences
    Beijing, China
  • Tianjin Medical University Cancer Institute and Hospital
    Tianjin, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02591784
Lead sponsor
Biotech Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Oct 30, 2015
Start date
Nov 2008
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Mar 17, 2022

Study contacts

Lvhua Wang
principal investigator · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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