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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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The study is to evaluate the efficacy and safety of Apatinib as maintenace therapy for Nasopharyngeal Carcinoma With Metastasis after Chemoradiotherapy, including progress free survival(PFS)、overall survival (OS)、Quality of life score (QoL) and evaluation of drug safety.
In locally advanced nasopharyngeal carcinoma(NPC), although radiotherapy and chemotherapy has been given, patients still locally recurrence and distant metastasis. There is no standard treatment recommendation for metastatic NPC who failed to chemoradiotherapy therapy. Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III studies of liver cancer, non small cell lung cancer and other tumors also showed apatinib has less toxicities and better tolerance. However, the clinical application of apatinib in nasopharyngeal carcinoma is still lack of evidence-based medicine. And this trial is designed to investigate the efficacy and safety of apatinib as maintenance therapy after chemoradiotherapy in nasopharyngeal carcinoma with metastasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apatinib | Experimental | apatinib,500mg,qd,28 day/cycle until the emergence of PD, death, intolerable toxicity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR2, also known as KDR). It is an orally bioavailable, small molecule agent which is thought to inhibit angiogenesis in cancer cells; specifically apatinib inhibits VEGF-mediated endothelial cell migration and proliferation thus blocking new blood vessel formation in tumor tissue. This agent also mildly inhibits c-Kit and c-SRC tyrosine kinases. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The first day of treatment to the date that disease progression is reported | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | the first day of treatment to death or last survival confirm date. | up to 24 months |
| Quality of Life (QoL) questionnaire | in cancer patients and survivors with dermatologic conditions. This is a nontherapeutic and nondiagnostic protocol to obtain quality of life assessments from cancer patients and survivors who have dermatologic conditions, whether related to cancer therapies, or directly related to the primary cancer diagnosis. Data will be collected by using one or more dermatology-specific QoL instruments based on the underlying skin condition/s. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mei Feng | Sichuan Cancer Hospital and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital | Chengdu | Sichuan | 600000 | China |
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| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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|
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| up to 24 months |
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |