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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab | Experimental | the nimotuzumab treatment: 2 levels (400 mg/w, 600 mg/w, weekly, until disease progression) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nimotuzumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation | 6 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhihao Lu, MD | Contact | 86-10-88196561 | pppeirain@126.com | |
| Lin Shen, MD | Contact | 86-10-88196561 | lin100@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lin Shen, MD | Peking Universtiy Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
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| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |