Study of Nimotuzumab to Treat Esophageal Squamous Cell Carcinoma.

Study Overview
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Brief Summary
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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.

Official Title
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Phase IIa Study of Nimotuzumab in Second or Late- Line Treatment of Patients With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinomas

Conditions
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Esophageal Squamous Cell Cancer

Intervention / Treatment
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* Drug: nimotuzumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nimotuzumab<br>the nimotuzumab treatment: 2 levels (400 mg/w, 600 mg/w, weekly, until disease progression) | Drug: nimotuzumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | participants will be followed for the duration of hospital stay, an expected average of 1 week | during the treatment in the hosptital,an expected average of 1 week |