A Phase 2 interventional study of Sorafenib and Gemcitabine in Renal Cell Carcinoma, sponsored by Peking University Cancer Hospital & Institute. Completed at 5 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-11-20.
Sponsored by Peking University Cancer Hospital & Institute · Phase 2, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 26 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 are open to participants now.
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Exclusion Criteria:
this trial is designed single arm. all the subjects enrolled will receive the experimental intervention,ie. sorafenib+gemcitabine+cisplatin.
Drug: Sorafenib · Drug: Gemcitabine · Drug: Cisplatin
Sorafenib 400mg BID by oral until progressed;
Also known as: Nexavar
Gemcitabine: 1000mg/m2, administered by intravenous drip for 30\~60min on Day 1 and 8,for 4 cycles;
Also known as: Gemzar
Cisplatin: 25mg/m2, administered by intravenous drip on Day 1-3, with appropriate liquid hydration,for 4 cycles.
Also known as: Cis-Dichlorodiamineplatinum
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
objective response rate (ORR)
CR:complete response PR:partial response ORR:CR+PR
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
overall survival (OS)
Time from enrollment to the dates of death from any cause or last follow up reported between date of first patient enrollment until 30 June 2015 cut of date
Time frame: Time from enrollment to the dates of death from any cause or last follow up reported between date of first patient enrollment until 30 June 2015 cut of date
the rate of progress-free survive
the proportion of patients who don't experience progress at 3,6,9 months after enrollment
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
Plan to share: Undecided
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Peking University Cancer Hospital & Institute