Sorafenib Combined With Cisplatin and Gemcitabine for the Treatment of Patients With Advanced Renal Collecting Duct Carcinoma:A Pilot, Open Study
Collecting duct carcinoma(CDC) of the kidney is a rare and aggressive neoplasm of the distal
collecting tubules for which there is no established treatment. Since the histology of
collecting duct carcinoma is similar to that of urothelial carcinoma, a prospective phase II
trial in France(2007) studied gemcitabine plus cisplatin as the first-line treatment of
advanced CDC, resulting an effective rate of 26%. The targeted drugs can produce definite
efficacy on renal clear cell carcinoma, but the data on targeted drugs for the treatment of
renal advanced collecting duct carcinoma is limited. We sponsored this study based on the
assumption that targeted drugs combined with chemotherapy can produce additive, positive
effects in CDC.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause.
Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment until 30 June 2015 cut of date
Jun Guo, MD,PHD
Beijing Cancer Hospital
China: Food and Drug Administration