Randomized,Double-blind,Placebo-controlled,Multicenter Study to Compare the Efficacy and Safety of Anlotinib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies(ALTER0703)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 29
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.
详细描述
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.To compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent；
- •Histological or cytological documentation of adenocarcinoma of the colon or rectum；
- •Subjects with metastatic colorectal cancer (Stage IV),With measurable disease (using RECIST1.1)；
- •Progression during or within 3 months following the last administration of approved standard therapies which must include Fluorouracil or its derivatives, Oxaliplatin, Irinotecan；
- •ECOG PS:0-1,Life expectancy of more than 3 months；
- •main organs function is normal；
- •main organs function is normal；
排除标准
- •Prior treatment with Anlotinib；
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug；
- •Known brain metastases；
- •patients with severe and failed to controlled diseases；
- •patients occurred venous thromboembolic events within 6 months；
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)
Placebo
Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From randomization until death (up to 24 months)
次要结局
- Progress free survival (PFS)(each 42 days up to PD or death(up to 24 months))
- Disease Control Rate (DCR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
- Objective Response Rate (ORR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Until 30 day safety follow-up visit)