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Study of Nimotuzumab to Treat Esophageal Squamous Cell Carcinoma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993784
Recruitment Status : Unknown
Verified November 2013 by Shen Lin, Peking University.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Peking University

Brief Summary:
Nimotuzumab 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 study assessed the safety and efficacy of different dosage of Nimotuzumab in second or late- line treatment of patients with locally advanced or metastatic esophageal squamous cell carcinomas.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Cancer Drug: nimotuzumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IIa Study of Nimotuzumab in Second or Late- Line Treatment of Patients With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinomas
Study Start Date : August 2013
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nimotuzumab
the nimotuzumab treatment: 2 levels (400 mg/w, 600 mg/w, weekly, until disease progression)
Drug: nimotuzumab



Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 6 weeks ]
    CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation


Secondary Outcome Measures :
  1. adverse events [ Time Frame: during the treatment in the hosptital,an expected average of 1 week ]
    participants will be followed for the duration of hospital stay, an expected average of 1 week



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed esophageal squamous carcinoma,failed to first or second line chemothrepay
  • Age 18 to 75 years old
  • Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
  • Life expectancy of ≥3 month
  • Karnofsky performance status ≥80
  • WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>100,000/mm3, Hb>9g/dl,Bilirubin level < 1.0 times ULN,Serum creatinine <1.0 times ULN,ALT and AST<2.5 times ULN ,AKP < 2.5 times ULN ,(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
  • No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃;
  • Normal ECG/cardiac function
  • Good compliance
  • Having signed informed consent -

Exclusion Criteria:

  • No previous systemic therapy for metastatic esophageal squamous carcinoma
  • Known hypersensitivity to study drugs
  • Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
  • No measurable lesions, eg. pleural fluid and ascites
  • Only with Other previous malignancy within 5 year, except non-melanoma skin cancer
  • Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only Brain or bone metastasis
  • Chronic diarrhea
  • Mentally abnormal or disable cognition,including CNS metastasis
  • Pregnancy or lactation period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993784


Contacts
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Contact: Zhihao Lu, MD 86-10-88196561 pppeirain@126.com
Contact: Lin Shen, MD 86-10-88196561 lin100@medmail.com.cn

Locations
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China, Beijing
Peking University Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Lin Shen, MD    +86-10-88196561    lin100@medmail.com.cn   
Principal Investigator: Lin Shen         
Sponsors and Collaborators
Peking University
Investigators
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Principal Investigator: Lin Shen, MD Peking Universtiy Cancer Hospital
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Responsible Party: Shen Lin, Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute, Peking University
ClinicalTrials.gov Identifier: NCT01993784    
Other Study ID Numbers: ESCC-N-301
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Nimotuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents