Sound wave therapy may spark immune attack on liver tumors
NCT ID NCT07361107
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early study tests whether a non-invasive sound wave procedure called histotripsy can stir up the immune system in people with colorectal cancer that has spread to the liver. Researchers will take blood samples before and after treatment to see if T-cells become more active. Only 12 people will take part, and the goal is to understand the immune response, not yet to treat the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Histotripsy (a non-invasive procedure using sound waves to destroy tumors)
- What this could lead to
- If it works, this could point toward combining histotripsy with immunotherapy to better treat colorectal cancer that has spread to the liver.
- What could go wrong
- This is a very early, small pilot study with only 12 people. It is designed to measure immune changes, not to prove the treatment works. The results may not lead to any new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: 1. Absolute neutrophil count: ≥ 1,000/mcL 2. Platelets: ≥ 100,000/mcL 3. Total bilirubin ≤ 3x the upper limit of normal (ULN). This may be up to 5x ULN if Gilbert's syndrome is documented. 4. AST and ALT ≤ 8x institutional ULN. 5. Serum creatinine ≤ 2x ULN unless on dialysis. * 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 Criteria: * 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). v. 3.0 22July2025 9 * Serious cardiac arrhythmia (controlled atrial fibrillation or definitively treated arrhythmias via ablation are not considered exclusion criteria). * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zuckerberg Cancer Center
RECRUITINGNew Hyde Park, New York, 11040, United States
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