About this trial
This is a single-center, non-randomized, open-label, single-arm pilot study investigating the systemic immune response to histotripsy in patients with colorectal cancer with liver metastasis. Histotripsy is an FDA-approved, non-invasive therapeutic modality for the treatment of liver tumors, including both primary and metastatic lesions. In this study, investigators aim to evaluate the kinetics of peripheral T-cell response following histotripsy of colorectal cancer liver metastases (CRCLM). Given the well-documented immune-tolerant tumor microenvironment of liver metastases and their role in systemic resistance to checkpoint inhibitors, investigators hypothesize that histotripsy-induced tumor disruption will lead to measurable alterations in peripheral T-cell clonal expansion and exhaustion markers. Investigators will assess these changes via serial blood draws before and after histotripsy, with the goal of characterizing the systemic immune impact of local tumor ablation. Findings from this study may inform future combination strategies integrating histotripsy with immunotherapy to enhance treatment response in microsatellite-stable CRC
Eligibility criteria
Qualifiers
Gender: Both male and female patients will be eligible for enrollment.
Age at least 18 years.
Histologic (biopsy-proven) confirmation of metastatic microsatellite stable colorectal cancer with at least one radiographically evident hepatic metastasis.
Planned treatment with standard-of-care histotripsy.
Disqualifiers
Major surgical procedure or significant traumatic injury within 14 days prior to histotripsy.
Therapy with an investigational drug within 14 days prior to histotripsy.
Myocardial infarction within 3 months prior to enrollment.
Unstable angina.
Trial design
Treatments tested in this trial
- Histotripsy