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Nimotuzumab, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in some studies with head-neck cancers. Advanced esophageal carcinoma have poor prognosis and majority of patients resistant to chemotherapy in China. In the investigators phase II clinical trial proceeded before,the combination of paclitaxel with cisplatin showed good tolerance and efficacy to esophageal carcinoma. The investigators then initiated a prospective phase II clinical trial with Nimotuzumabplus paclitaxel/cisplatin as the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of the combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab 200mg/week |
|
| 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 |
|---|---|---|
| overall survival of all participants | OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost | 2 years |
| progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaodong zhang, MD | Contact | 86-01-88196175 | zxd0829@yahoo.com.cn | |
| jifang gong, MD | Contact | 86-01-88196088 | gongjifang@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiaodong Zhang | 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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the follow-up visit of PFS will be performed every 2 cycles
| 1 year |
| adverse events | any adverse event will be record on CRF for safety control | participants will be followed for the duration of hospital stay, an expected average of 1 week |
| 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 |