Abstract
e15554 Background: Collecting duct carcinoma (CDC) of the kidney is a rare and aggressive neoplasm without any approved treatment. The anti-VEGF drugs can produce definite efficacy on renal clear cell carcinoma, but it is limited for advanced CDC. This study was designed to evaluate the efficacy and safety of sorafenib combined with cisplain plus gemcitabine in patients with advanced CDC without prior systemic chemotherapy or anti-VEGF therapy. Methods: This study is an open-label, multicenter, single-arm phase II trial. Up to 20 adult patients with metastatic, recurrent, or unresectable RCC of any MSKCC prognosis and histological confirmation of CDC, ≥1 measurable baseline lesion as per RECIST criteria, ECOG PS ≤2, and adequate liver, renal, and bone marrow function are targeted for enrollment. All patients received sorafenib (400mg Bid) combined with cisplatin plus gemcitabine (cisplatin: 25mg/m2, D1-3; gemcitabine: 1000 mg/m2, D1-8, for 4 cycles) until disease progression, unacceptable toxicity, or stu...
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