Sorafenib Combined With Cisplatin and Gemcitabine for the Treatment of Patients With Advanced Renal Collecting Duct Carcinoma:A Pilot, Open Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 5
- 主要终点
- progress-free survival,PFS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 therapy (excluding β-blockers or digoxin), and uncontrolled hypertension;
- •Patients with a history of HIV infection or active phase of chronic hepatitis B/C;
- •negative imaging examination result 4 weeks prior to enrollment);
- •Epilepsy patients requiring drug therapy (e.g. steroids or antiepileptic drugs);
- •A history of allogeneic organ transplantation;
- •Patients with evidence of hemorrhagic constitution or a past history of hemorrhage;
- •Patients currently receiving renal dialysis;
- •Past or present concomitant tumors with the primary lesions or histological characteristics different from the tumors evaluated in this study, excluding other tumor cured longer than 3 years before enrollment;
- •Patients participating in other clinical trials simultaneously;
- •Other conditions unsatisfying the inclusion criteria in the investigator's opinions.
研究组 & 干预措施
sorafenib combined with chemotherapy
this trial is designed single arm. all the subjects enrolled will receive the experimental intervention,ie. sorafenib+gemcitabine+cisplatin.
干预措施: Sorafenib (Drug)
sorafenib combined with chemotherapy
this trial is designed single arm. all the subjects enrolled will receive the experimental intervention,ie. sorafenib+gemcitabine+cisplatin.
干预措施: Gemcitabine (Drug)
sorafenib combined with chemotherapy
this trial is designed single arm. all the subjects enrolled will receive the experimental intervention,ie. sorafenib+gemcitabine+cisplatin.
干预措施: Cisplatin (Drug)
结局指标
主要结局
progress-free survival,PFS
时间窗: 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
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause.
次要结局
- adverse event, AE(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)
研究者
Jun Guo
Director of renal cancer and melanoma department
Peking University Cancer Hospital & Institute