A Randomized, Positive-controlled, Multicenter, Phase II Study of Anlotinib(AL3818) in Patients With Advanced Renal Cell Carcinoma(RCC)
试验速览
- 阶段
- 2 期
- 入组人数
- 133
- 试验地点
- 15
- 主要终点
- Progress free survival (PFS)
研究概览
简要总结
Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to compare the efficacy and safety profile between Anlotinib and Sunitinib in patients with advanced Renal Cell Carcinoma(RCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery
- •2.Without drug treatment for RCC or chemotherapy/cytokine therapy failure or resistant patients)
- •3.With measurable disease (using RECIST1.1)
- •4.18-75years,ECOG PS:0-1,Life expectancy of more than 3 months
- •5.Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks
- •6.main organs function is normal
- •7.Signed and dated informed consent
排除标准
- •1.Previously received targeted therapy of the metastatic renal cell carcinoma (such as sunitinib, Sorafenib)
- •2.patients has many influence factors toward oral medications
- •3.Known brain metastases
- •4.patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)>10mmol/L);urine protein≥++,etc.
- •5.patients failed to heal wounds or fractures for Long-term
- •6.patients occurred venous thromboembolic events within 6 months
- •7.patients has HIV-positive or organ transplantation
研究组 & 干预措施
Anlotinib
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Anlotinib (Drug)
Sunitinib maleate
Sunitinib 50 mg qd p.o., 4 weeks out of 6.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
干预措施: Sunitinib maleate (Drug)
结局指标
主要结局
Progress free survival (PFS)
时间窗: each 42 days up to PD or death(up to 36 months)
The PFS time is defined as time from randomization to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of: "death", "last tumor assessment", "last follow up date" or "last date in drug log".
次要结局
- Objective Response Rate(each 42 days up to intolerance the toxicity or PD (up to 36 months))
- Disease Control Rate (DCR)(each 42 days up to intolerance the toxicity or PD (up to 36 months))
- Overall Survival (OS)(From randomization until death (up to 36 months))