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ECHO-CRC Study: Histotripsy for Colorectal Cancer with Liver Metastasis

This study, called ECHO-CRC, is looking at how a treatment called histotripsy affects the immune system in people with colorectal cancer that has spread to the liver. Histotripsy is a non-invasive procedure, already approved by the FDA, that uses sound waves to treat liver tumors. Researchers want to see if histotripsy changes your body's immune cells (specifically T-cells) to better fight the cancer. You may be able to join if you are at least 18 years old, have colorectal cancer that has spread to your liver, and are planning to receive histotripsy as part of your standard care. The main goal is to measure how your immune system changes over two years after the treatment. The study is currently unclear on its recruitment status and plans to enroll 12 participants.

Study design
This is a single-center, non-randomized, open-label, single-arm pilot study. It plans to enroll 12 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your immune system changes will be measured for up to 2 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07361107

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Northwell Health
~12 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:Histotripsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measure of System Immune Modulation via T-cells
Measured over 2 years

Conditions

Colorectal (Colon or Rectal) Cancer

Explore related trials

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Where it's being run

1 sites across 1 states
New York1

Who to contact

GI Referral Team GI Referral Team
[email protected]
516-734-8900
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Radiographic confirmation of hepatic metastases with computed tomography (CT) or magnetic resonance imaging (MRI), with CT preferred. Imaging must be performed within 60 days of the date of consent.
Adequate organ and marrow function as defined below:
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3.
Estimated life expectancy of at least 90 days as determined by the treating physician.
Demographic group: There are no restrictions based on race or ethnicity. Efforts will be made to ensure a representative patient population reflecting the diversity of individuals affected by CRCLM.
Ability to understand and willingness to sign a written informed consent document.

Exclusion

Major surgical procedure or significant traumatic injury within 14 days prior to histotripsy.
Therapy with an investigational drug within 14 days prior to histotripsy.
Clinically significant cardiovascular or cerebrovascular disease, including:
Myocardial infarction within 3 months prior to enrollment.
Unstable angina.
Congestive heart failure (New York Heart Association Classification Class \> II).
Cerebrovascular stroke with deficit within 3 months prior to enrollment.
Active infection requiring systemic therapy within 14 days prior to histotripsy, unless deemed to be a chronic disease state by the study PI.
Active pregnancy.
Patients with active infections, autoimmune diseases requiring systemic immunosuppression, or other uncontrolled comorbidities that could interfere with study participation will be excluded.
Severe cancer-associated cachexia that may interfere with systemic immune response, as assessed by the treating physician.
Any ongoing medical illness or injury that would significantly impact tolerability of therapy, including but not limited to:
Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture.
Clinical signs or symptoms of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding.
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates histotripsy, may affect the interpretation of study results, or may render the patient at high risk for treatment complications.
Anyone that is unable to consent due to cognitive, psychological or other reasons that impact their capacity.
Deemed to be inappropriate for enrollment by the study PI.

What this trial measures

  • Measure of System Immune Modulation via T-cells2 years

    To evaluate whether histotripsy of CRCLM induces systemic immune modulation, as measured by changes in peripheral T-cell clonal expansion and markers of T-cell exhaustion. Change in peripheral T-cell clonal expansion measured in the week prior to histotripsy, directly after histotripsy, and at 14, 28, and 90 days following histotripsy. Change in markers of T-cell exhaustion measured in the week prior to histotripsy, directly after histotripsy, and at 14, 28, and 90 days following histotripsy.