Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07361107

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

Led by Northwell Health · Updated on 2026-01-22

12

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 18 years or older
  • Histologic confirmation of metastatic microsatellite stable colorectal cancer with at least one liver metastasis visible on imaging
  • Planned to receive standard-of-care histotripsy treatment
  • Liver metastases confirmed by CT or MRI within 60 days prior to consent, with CT preferred
  • Adequate organ and marrow function: neutrophils 61,000/mcL, platelets 6100,000/mcL, total bilirubin 4x upper limit of normal (up to 5x if Gilbert's syndrome), AST and ALT 48x upper limit of normal, serum creatinine 42x upper limit of normal unless on dialysis
  • Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 3
  • Estimated life expectancy of at least 90 days per treating physician
  • No restrictions based on race or ethnicity
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Major surgery or significant injury within 14 days prior to histotripsy
  • Use of investigational drugs within 14 days prior to histotripsy
  • Significant cardiovascular or cerebrovascular disease, including:
  • Myocardial infarction within 3 months prior to enrollment
  • Unstable angina
  • Congestive heart failure greater than New York Heart Association Class II
  • Serious cardiac arrhythmia (controlled atrial fibrillation or treated arrhythmias via ablation allowed)
  • Stroke with deficit within 3 months prior to enrollment
  • Active infection needing systemic treatment within 14 days prior to histotripsy unless chronic disease
  • Active pregnancy
  • Active infections, autoimmune diseases needing systemic immunosuppression, or other uncontrolled comorbidities
  • Severe cancer-associated cachexia interfering with immune response
  • Serious wounds, ulcers, or untreated fractures
  • Gastrointestinal obstruction or need for parenteral hydration, nutrition, or tube feeding
  • Any condition contraindicating histotripsy or increasing risk of complications
  • Inability to consent due to cognitive or psychological reasons
  • Deemed inappropriate for enrollment by study investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Zuckerberg Cancer Center

New Hyde Park, New York, United States, 11040

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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