Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Radiologic tumor viability
研究概览
简要总结
The goal of this clinical trial is to learn if histotripsy plus chemotherapy works to treat unresectable, bilobar liver- confined colorectal cancer liver metastasis (CRLM). The main question this clinical trial aims to answer is:
• Does the management of this condition with uninterrupted palliative chemotherapy and histotripsy demonstrate improved progression-free survival?
Participants will:
- Receive chemotherapy treatment per standard procedure.
- Undergo histotripsy treatment according to current standard procedures at Cleveland Clinic.
- Occasionally receive Computerized Tomography (CT) scan with and without contrast, give biopsy of treated and untreated liver lesions, and participate in a blood draw of up to 3 teaspoons at each in-person visit.
- Participate in genetic testing, as a part of the standard of care for the treatment.
详细描述
This is a prospective trial testing the benefits of histotripsy plus chemotherapy for participants with colorectal liver metastasis. Histotripsy has been approved by the FDA with De Novo classification for non-invasive destruction of liver tumors. Up to 100 participants with colorectal cancer liver metastasis will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Participants with liver-confined colorectal cancer liver metastasis (CRLM) or participants who have low-volume pulmonary disease along with CRLM
- •Participants receiving first line therapy with base of 5-FU with either oxaliplatin or irinotecan, or who are within 3 months of beginning chemotherapy, or participants who have completed chemotherapy treatment within 1 month of the histotripsy evaluation
- •Participants who have undergone other liver-directed therapy, such as ablation, embolization
- •Participants with multiple unresectable metastases that cannot be completely treated with resection and/or ablation
- •Participants aged ≥18 years
排除标准
- •Participants with resectable disease
- •Participants with non-pulmonary extra-hepatic disease including but not limited to bone or peritoneal metastasis.
- •Participants who are not able to tolerate general anesthesia
- •Participants who have Childs C Cirrhosis
- •Other non-skin malignancy within 2 years of study
- •WBC count < 3,000 /uL
- •Absolute Neutrophil Count < 1,500 /uL
- •History of Non-malignant serious concurrent illness that would increase the risk of histotripsy
- •Participants with MSI-High
- •Participants aged < 18 years
- •Pregnant participants
研究组 & 干预措施
Histotripsy + Chemotherapy
All enrolled participants will undergo combined treatment with Histotripsy and chemotherapy without interruption in the chemotherapy.
干预措施: Chemotherapy (Drug)
Histotripsy + Chemotherapy
All enrolled participants will undergo combined treatment with Histotripsy and chemotherapy without interruption in the chemotherapy.
干预措施: HistoSonics Edison® System (Device)
结局指标
主要结局
Radiologic tumor viability
时间窗: 90 days post-treatment
As assessed by the degree of short-term local tumor control in Colorectal Liver Metastasis(CRLM)
Radiologic tumor viability
时间窗: 90 days post-treatment
As assessed by the degree of short-term local tumor control in Colorectal Liver Metastasis(CRLM)
次要结局
- Rate of Tumor Necrosis(30 days post-treatment)
- Percentage of Viable Tumor in Lesion(30 days post-treatment)
- Infiltration of B-cells(30 days post- treatment)
- Infiltration of CD4(30 days post-treatment)
- Infiltration of CD8(Baseline, 30 days post-treatment)
- Infiltration of PD-1(30 days post-treatment)
- Overall Survival(Up to 24 months post-treatment)
- Infiltration of CD45(30 days post-treatment)
- Infiltration of CD68(30 days post-treatment)
- Infiltration of PD-L1(30 days after treatment)
- Infiltration of CTLA-4(30 days post-treatment)
- Progression Free Survival (PFS)(Up to 24 months post-treatment)
- 30 day Complications(30 days post-treatment)
- 90 day Complications(90 days post-treatment)
- Rate of Tumor Necrosis(30 days post-treatment)
- Percentage of Viable Tumor in Lesion(30 days post-treatment)
- Infiltration of CD4(30 days post-treatment)
- Infiltration of CD8(Baseline, 30 days post-treatment)
- Infiltration of B-cells(30 days post- treatment)
- Infiltration of CD45(30 days post-treatment)
- Infiltration of CD68(30 days post-treatment)
- Infiltration of PD-1(30 days post-treatment)
- Infiltration of PD-L1(30 days after treatment)
- Infiltration of CTLA-4(30 days post-treatment)
- Overall Survival(Up to 24 months post-treatment)
- Progression Free Survival (PFS)(Up to 24 months post-treatment)
- 30 day Complications(30 days post-treatment)
- 90 day Complications(90 days post-treatment)