Early Therapeutic Monitoring of Response to Therapy With Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Initial Objective Response- First Participation
研究概览
简要总结
To assess whether changes in quantitative tumor perfusion parameters after 3 or 6 weeks of treatment, as measured by power Doppler ultrasound, can predict initial objective response, defined by current standard-of-care, to therapy at 12 weeks after start of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •18 years of age or older
- •Pathology-confirmed diagnosis of Renal cell carcinoma (RCC)
- •At least one tumor lesion greater than 1 cm in diameter, amenable to ultrasound imaging
- •Written informed consent.
- •Specific inclusion criteria:
- •Arm 1: planned to be treated with combination of VEGFR2 tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
- •Arm 2: planned to be treated with non-ICI therapy
排除标准
- •Any comorbid condition that, in the opinion of the treating provider or the Protocol Directors, compromises the participant's ability to participate in the study
研究组 & 干预措施
Tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
Patients are planned to be treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
干预措施: Doppler Ultrasound (Diagnostic Test)
Tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
Patients are planned to be treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
干预措施: SIEMENS S3000 and Verasonics Vantage 256 (Device)
Tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
Patients are planned to be treated with vascular endothelial growth factor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
干预措施: Standard-of-care Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI) (Drug)
Non-ICI therapy
Patients are planned to be treated with non-ICI therapy
干预措施: Doppler Ultrasound (Diagnostic Test)
Non-ICI therapy
Patients are planned to be treated with non-ICI therapy
干预措施: SIEMENS S3000 and Verasonics Vantage 256 (Device)
Non-ICI therapy
Patients are planned to be treated with non-ICI therapy
干预措施: Standard-of-care non-immune checkpoint inhibitor (ICI) such as single-agent VEGFR2 TKI (Drug)
结局指标
主要结局
Initial Objective Response- First Participation
时间窗: 12 weeks
Initial objective response was defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1 at first on-treatment response evaluation 8-16 weeks after initiating treatment.
Initial Objective Response- Second Participation
时间窗: 12 weeks
Initial objective response is defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1 at first on-treatment response evaluation 8-16 weeks after initiating treatment.
次要结局
- Initial Relative Change in Tumor Burden Compared to Baseline - First Participation(8-16 weeks after the start of treatment)
- Initial Relative Change in Tumor Burden Compared to Baseline - Second Participation(8-16 weeks after the start of treatment)
- Initial Per-Lesion Response Compared To Baseline - First Participation(12 weeks)
- Initial Per-Lesion Response Compared To Baseline - Second Participation(12 weeks)
- 12-month Progression Free Survival (PFS)- First Participation(12 months)
- 12-month Progression Free Survival (PFS)- Second Participation(12 months)
研究者
Alice Fan
Assistant Professor of Medicine
Stanford University