An Open Label Phase II Study for the Treatment of Liver Metastatic Colorectal Cancer and Non-Small Cell Lung Cancer With a Combination of TATE (Trans-Arterial Tirapazamine Embolization) and Pembrolizumab
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Overall Survival for the mCRC cohort
研究概览
简要总结
Patients with refractory metastatic colorectal cancer or non-small cell lung cancer with liver metastasis treated with Trans-arterial Tirapazamine Embolization along with Pembrolizumab.
详细描述
This study is an open-label study to treat patients with refractory metastatic colorectal cancer and non-small cell lung cancer with liver metastasis. Patients enrolled in the mCRC cohort will be randomized to receive study treatment Trans-arterial Tirapazamine Embolization (TATE)+Pembrolizumab or FDA-approved standard of care, such as TAS-102 or regorafenib, and their Overall Survival (OS) will be compared in the two cohorts as the primary endpoint. Patients enrolled in the NSCLC cohort will all receive study treatment TATE+Pembrolizaumb and Overall Response Rate (ORR) will be the primary endpoint.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver metastatic MSS-mCRC or NSCLC without EGFR or AKT mutations
- •mCRC progressed on at least two lines of standard chemotherapy; or
- •NSCLC progressed on chemotherapy and an immune checkpoint inhibitor
- •Measurable disease
- •At least 4 weeks from prior chemotherapy and free from chemo-related toxicity
- •Adequate organ function
排除标准
- •Prior organ transplantation
- •Liver metastasis more than 50%
- •Oxygen saturation less than 92% in room air
- •Prior autoimmune disorder
- •CNS metastasis
- •Major GI bleeding in the last 2 months
研究组 & 干预措施
colorectal cancer
metastatic colorectal cancer progressed on at least two lines of chemotherapy
干预措施: TAS-102 pill (Drug)
colorectal cancer
metastatic colorectal cancer progressed on at least two lines of chemotherapy
干预措施: Regorafenib Pill (Drug)
NSCLC
Liver metastatic NSCLC progressed on immune checkpoint inhibitors and chemotherapy
干预措施: TATE and pembrolizumab (Drug)
colorectal cancer
metastatic colorectal cancer progressed on at least two lines of chemotherapy
干预措施: TATE and pembrolizumab (Drug)
结局指标
主要结局
Overall Survival for the mCRC cohort
时间窗: 24 months
From the first day of treatment to death
Overall Response Rate (ORR) for the NSCLC cohort
时间窗: within 24 months
Per RECIST 1.1 criteria
次要结局
- Duration of Response(24 months)
- Response rate(24 months)
- PFS(24 months)
- TTP(24 months)