The goal of this clinical research study is to learn the effectiveness of sorafenib combined with gemcitabine plus cisplatin in the treatment of patients with locally advanced or metastatic collecting duct carcinoma(CDC) of the kidney. The safety of each treatment will also be studied.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Sorafenib 400mg BID by oral until progressed;
Gemcitabine: 1000mg/m2, administered by intravenous drip for 30\~60min on Day 1 and 8,for 4 cycles;
Cisplatin: 25mg/m2, administered by intravenous drip on Day 1-3, with appropriate liquid hydration,for 4 cycles.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen university cancer center
Guangzhou, Guangdong, China
Shenyang general hospital of Shenyang military command
Shenyang, Liaoning, China
Xijing Hospital
Xi’an, Shanxi, China
progress-free survival,PFS
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause.
Time frame: 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
adverse event, AE
Any events,no matter related to interventions,occur during the period from the enrollment to death or 30 days after withdrawal from the trial
Time frame: 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
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West China Hospital
Chengdu, Sichuan, China