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NCT Number: NCT02591784

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.

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Key information

Conditions

Esophageal

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Affiliated tumour hosiptal of HARBIN Medical University, Harbin, Heilongjiang, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Nimotuzumab

Drug

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

Radiotherapy

Radiation

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

Primary outcomes

  1. 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

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

Sponsors and collaborators

Lead sponsor

Biotech Pharmaceutical Co., Ltd.

Other

Registry information

Official study title

The Phase II of Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 30, 2015
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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