RecruitingPhase 1NCT07361107

Evaluation of Circulating Immune Response After Histosonics in Colorectal Cancer (ECHO-CRC)

Sponsor

Northwell Health

Enrollment

12 participants

Start Date

Sep 26, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal (Colon or Rectal) Cancer

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether a non-surgical tumor destruction technique called histotripsy (which uses focused sound waves to destroy tumors in the liver) also triggers an immune response that may help fight colorectal cancer that has spread to the liver. **You may be eligible if...** - You are 18 or older - You have microsatellite stable (MSS) metastatic colorectal cancer with at least one tumor in the liver, confirmed by imaging and biopsy - You are already scheduled to receive standard-of-care histotripsy for your liver tumor - Your blood counts, liver, and kidney function are within acceptable ranges - Your overall health allows treatment (ECOG 0–3) - Your expected survival is at least 90 days **You may NOT be eligible if...** - You had major surgery or a serious injury within the past 14 days - You are currently enrolled in another interventional trial - You are pregnant or breastfeeding - You have conditions that would prevent safe study participation per your doctor's judgment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHistotripsy

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, we 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, we hypothesize that histotripsy-induced tumor disruption will lead to measurable alterations in peripheral T-cell clonal expansion and exhaustion markers. We 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