A prospective multicenter phase II study of sorafenib combined with cisplatin plus gemcitabine for the treatment of patients with advanced renal collecting duct carcinoma (NCT01762150).

Abstract

4559Background: 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 limited for advanced CDC. Gemcitabine plus cisplatin (GC) has showed some activity in patients with advanced CDC. This study was designed to evaluate the efficacy and safety of sorafenib combined with GC as first line treatment in patients with advanced CDC. Methods: This study is a prospective multicenter, single-arm phase II trial. Patients with metastatic, or unresectable CDC by central pathological confirmation and ≥ 1 measurable lesion per RECIST criteria, ECOG PS ≤ 2, and adequate organ function are enrolled. All patients received sorafenib (400mg Bid) combined with GC (cisplatin: 25mg/m2, d1-3; gemcitabine: 1000 mg/m2, d1,d8, for 4 cycles) until disease progression, unacceptable toxicity, or study discontinuation for any other reason. The primary endpoint is PFS. Overall survival, disease ...