Back to resultsStudy of Nimotuzumab to Treat Esophageal Squamous Cell Carcinoma.
Primary Purpose
Esophageal Squamous Cell Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
nimotuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Cancer
Eligibility 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
Sites / Locations
- Peking University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nimotuzumab
Arm Description
the nimotuzumab treatment: 2 levels (400 mg/w, 600 mg/w, weekly, until disease progression)
Outcomes
Primary Outcome Measures
Objective response rate
CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation
Secondary Outcome Measures
adverse events
participants will be followed for the duration of hospital stay, an expected average of 1 week
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01993784
Brief Title
Study of Nimotuzumab to Treat Esophageal Squamous Cell Carcinoma.
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 Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nimotuzumab
Arm Type
Experimental
Arm Description
the nimotuzumab treatment: 2 levels (400 mg/w, 600 mg/w, weekly, until disease progression)
Intervention Type
Drug
Intervention Name(s)
nimotuzumab
Primary Outcome Measure Information:
Title
Objective response rate
Description
CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
adverse events
Description
participants will be followed for the duration of hospital stay, an expected average of 1 week
Time Frame
during the treatment in the hosptital,an expected average of 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihao Lu, MD
Phone
86-10-88196561
Email
pppeirain@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Shen, MD
Phone
86-10-88196561
Email
lin100@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD
Organizational Affiliation
Peking Universtiy Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD
Phone
+86-10-88196561
Email
lin100@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Lin Shen
12. IPD Sharing Statement
Learn more about this trial
Study of Nimotuzumab to Treat Esophageal Squamous Cell Carcinoma.
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