跳至主要内容
临床试验/NCT03264274
NCT03264274撤回2 期

A Phase II Trial of Aflibercept Monotherapy With Early Dynamic Contrast Enhanced Ultrasound Monitoring in Chemorefractory Metastatic Colorectal Cancer

Barts & The London NHS Trust0 个研究点开始时间: 2017年2月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
主要终点
Overall survival

研究概览

简要总结

Various antiangiogenic agents have a modest effect in prolonging overall survival in solid tumours. In colorectal cancer it is clear that there are some patients in whom bevacizumab significantly prolongs survival, but it is not effective in the majority of patients. Biomarker studies using tumour tissue and blood have failed to define a consistent biomarker that correlates with a beneficial effect of bevacizumab on survival. DCE-MRI can detect changes in tumour blood flow which, in early phase drug studies, correlated with subsequent tumour responses, but is too expensive and time consuming to be used in larger scale trials. DCE-US is a promising biomarker for use in this group of patients with antiangiogenic agents, as detailed above. The investigators wish to use this technique as a predictive biomarker for any effects Aflibercept has on OS and PFS in patients with metastatic colorectal cancer refractory to standard treatment.

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

盲法说明

No masking

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Aflibercept + DCE-US

Other

Aflibercept: 4mg/kg IV every 2 weeks until discontinuation due to progression. DCE-US before treatment, and at 2 weeks and 8 weeks after the first Aflibercept administration.

干预措施: Aflibercept (Drug)

Aflibercept + DCE-US

Other

Aflibercept: 4mg/kg IV every 2 weeks until discontinuation due to progression. DCE-US before treatment, and at 2 weeks and 8 weeks after the first Aflibercept administration.

干预措施: Dynamic Contrast Enhanced Ultrasound (Procedure)

结局指标

主要结局

Overall survival

时间窗: 1 year

次要结局

  • Progression-free survival(1 year)

研究者

申办方类型
Other
责任方
Sponsor

相似试验

Trial of Aflibercept Monotherapy With DCE-US in... | 临床试验