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OpenTrials
Completed

NCT Number: NCT00950417

Nimotuzumab in Combination With Chemoradiation 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 I study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemo-radiotherapy in patients with locally advanced esophageal cancer tumours.

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Key information

Conditions

Advanced Esophageal

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent form signed before performing any of the study's specific procedures.
  • ECOG performance status 0-2.
  • Age > 18 and < 75.
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan and MRI or greater than or equal to 2 cm by other ordinary radiographic technique.
  • Histologically confirmed diagnosis of locally advanced esophageal.
  • Life expectancy of more than 3 months.
  • Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
  • No serious blood producing,abnormal function of heart,lung, liver, or kidney or immuno-deficiency
  • Neutrophils ≥3×109/L, platelet count≥100×109/L and haemoglobin≥9g/dL ,Creatinine ≤ 1.5 x NUL

Exclusion criteria

  • Previous radiotherapy or chemotherapy
  • Pregnant or breast-feeding women
  • Drug abuse, unhealthy drug/alcohol addiction,or virus (HIV) infection
  • Evidence of distant metastasis
  • Participation in other clinical trials
  • Patients with aphthosis, complete obstruction, fistula or deep peptic ulcer in the esophagus, or haematemesis
  • Uncontrolled psychiatric disease or seizure
  • Patients not fit for the clinical trial judged by the investigators

Treatment and study plan

Nimotuzumab

Drug

Primary outcomes

  1. Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.

    Time frame: within study period

Secondary outcomes

  1. To determine the complete response rate、partial rate、disease responserate、disease control rate in the patients subject to treatment

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Biotech Pharmaceutical Co., Ltd.

Other

Registry information

Official study title

Phase I Study of Nimotuzumab in Combination With Simultaneous Chemotherapy and Radiation for Patients With Locally Advanced Esophageal Cancer

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Jul 31, 2009
Registry last updated
Aug 19, 2015

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.