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The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC).
To evaluate the progression free survival (PFS), overall survival (OS), Acute adverse reaction of recombinant human endostatin (endostar) combined with chemotherapy to the metastatic nasopharyngeal carcinoma (NPC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endostatin | Experimental | chemotherapy concurrently with endostatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endostatin | Drug | Gemcitabine 1.0g/m2 d1,8 cisplatin 80mg/m2 endostatin 15mg/d 14days/cycle *4cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| progress free survival(PFS) | PFS means assignament to the date of any local or distant progress of the disease useing Kaplan-Meier caculate the progress free survival rates | 1 year and 2years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival(OS) | the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to caculate the 1-year ,2-year,3-year overall survival rate | baseline to date of death from any cause |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bin Li | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang cancer hospital | Hangzhou | Zhejiang | 310022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25198661 | Derived | Jin T, Li B, Chen XZ. A phase II trial of Endostar combined with gemcitabine and cisplatin chemotherapy in patients with metastatic nasopharyngeal carcinoma (NCT01612286). Oncol Res. 2013;21(6):317-23. doi: 10.3727/096504014X13983417587401. |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D043169 | Endostatins |
| C522911 | endostar protein |
| ID | Term |
|---|---|
| D043165 | Angiostatic Proteins |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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observe and record the toxicity profile(incluing but not limit to mocositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edtion) during the chemotherapy,Targeted therapy and follow-up
| participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 1 year |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D043170 | Collagen Type XVIII |
| D024041 | Non-Fibrillar Collagens |
| D003094 | Collagen |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D001685 | Biological Factors |