NCT05052723已完成2 期
Phase II Clinical Trial Evaluating Cabozantinib and Pembrolizumab in Metastatic Pancreatic Cancer
Joseph Kim1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年1月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
This study aims to evaluate cabozantinib and pembrolizumab for the treatment of metastatic pancreatic adenocarcinoma.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of pancreatic ductal adenocarcinoma
- •Evidence of progression or intolerance to previous standard of care pancreatic cancer systemic or locoregional therapies
- •Patients must have adequate organ function
排除标准
- •Chemotherapy or other locoregional anti-tumoral therapies performed within 28 days of study treatment initiation
- •Received palliative radiation therapy within 2 weeks or any other radiation therapy within 4 weeks of start of study intervention
- •Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation
- •Has a diagnosis of immunodeficiency (autoimmune disease) or is receiving chronic systemic steroid therapy
- •Clinically significant cardiovascular disease
- •Uncontrolled hypertension
- •Inability to swallow tablets
研究组 & 干预措施
Cabozantinib and pembrolizumab
Experimental
干预措施: Cabozantinib (Drug)
Cabozantinib and pembrolizumab
Experimental
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: 1 year
Progress-free survival in participants, defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever comes first.
次要结局
- Number of Participants With Response to Therapy(1 year)
- Number of Participants With Complete Response(1 year)
- Number of Participants With Partial Response(1 year)
- Overall Participant Survival Rate(1 year)
研究者
Joseph Kim
Professor
University of Kentucky
研究点 (1)
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