Sorafenib Combined With Chemotherapy for Renal Collecting Duct Carcinoma (NCT01762150) | Clinical Trial Compass
CompletedPhase 2
Sorafenib Combined With Chemotherapy for Renal Collecting Duct Carcinoma
China26 participantsStarted 2011-06
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Age≥18 years, ≤70 years, male or female;
* Advanced collecting duct carcinoma of the kidney is diagnosed histologically or pathologically ;
* Have not received anti-angiogenesis targeted drug therapy and systemic chemotherapy;
* Have at least one measurable tumor lesion (Response Evaluation Criteria In Solid Tumors);
* Eastern Cooperative Oncology Group(ECOG) performance scale is 0 or 1;
* The expected life span is ≥12 weeks;
* No contraindications for chemotherapy, with enough liver function and renal function and normal ECG recording.Peripheral hemogram: neutrophil≥1.5×109/L, Plt≥100×109/L, Hgb≥90 g/L;Renal function: serum creatinine≤1.5 folds the upper limit of normal (ULN); For patients with non-metastatic liver dysfunction: alanine aminotransferase and aspartate aminotransferase≤2.5 ULN, For patients with metastatic liver dysfunction: alanine aminotransferase and aspartate aminotransferase≤5 ULN;
* The patients participate voluntarily and have signed the informed consent form.
Exclusion Criteria:
* Pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures;
* Patients with severe acute infection without being controlled effectively or having pyogenic and chronic infections with persistently unhealed wounds;
* Past history of serious heart diseases, including: cardiac function classification ≥NYHA class II, unstable angina pectoris, myocardial infarction, arrhythmia requiring anti-arrhythmic drug th…
What they're measuring
1
progress-free survival,PFS
Timeframe: 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
Trial details
NCT IDNCT01762150
SponsorPeking University Cancer Hospital & Institute