【摘 要】
：
Objective: To compare the safety and adverse effects of sunitinib in treating metastatic renal clear-cell (mRCC) in China and phase Ⅲ trial.Methods: Open-label, single-arm, two centers clinical trial.
【机 构】
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Urology Department,the PLA General Hospital Urolo
【出 处】
：
第十三届亚洲泌尿外科学会年会(UAA2015)、第二十二届全国泌尿外科学术会议(CUA2015)、第十六届全军及武警泌尿
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Objective: To compare the safety and adverse effects of sunitinib in treating metastatic renal clear-cell (mRCC) in China and phase Ⅲ trial.Methods: Open-label, single-arm, two centers clinical trial.A total of 310 patients with mRCC were enrolled between Jun, 2008 and Dec.2014.256 cases were first line therapy and fifty-four cases were in progression on first-line cytokine or sorafinib therapy.The pathology of all patients was confirmed predominant in clear cell type.The sunitinib mono-therapy was administered in repeated 6-week cycles for 4 weeks, followed by 2 weeks off in 93 patients;and 17 patients were administered 37.5mg Qd continuously until disease progression or unacceptable toxicities occurred.The overall safety were evaluated.We also compared the difference between China and phase Ⅲ trial.
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