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Study of Nimotuzumab to Treat Esophageal Squamous Cell Carcinoma.

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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

Tracking Information
First Submitted Date  ICMJE August 16, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date November 25, 2013
Study Start Date  ICMJE August 2013
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
Objective response rate [ Time Frame: 6 weeks ]
CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Nimotuzumab to Treat Esophageal Squamous Cell Carcinoma.
Official Title  ICMJE Phase IIa Study of Nimotuzumab in Second or Late- Line Treatment of Patients With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinomas
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Squamous Cell Cancer
Intervention  ICMJE Drug: nimotuzumab
Study Arms  ICMJE Experimental: Nimotuzumab
the nimotuzumab treatment: 2 levels (400 mg/w, 600 mg/w, weekly, until disease progression)
Intervention: Drug: nimotuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 20, 2013)
9
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01993784
Other Study ID Numbers  ICMJE ESCC-N-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shen Lin, Peking University
Study Sponsor  ICMJE Peking University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lin Shen, MD Peking Universtiy Cancer Hospital
PRS Account Peking University
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP