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

NCT07361107•Northwell Health

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

Detailed Description

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 more criteria

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
•* 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.
+8 more criteria

Locations (1)

Zuckerberg Cancer Center

New Hyde Park, New York, United States

Key Dates

Start Date

September 26, 2025

Primary Completion Date

September 27, 2027

Completion Date

September 27, 2027

Last Updated

January 22, 2026

Enrollment

ESTIMATED participants

Conditions

Colorectal (Colon or Rectal) Cancer

Interventions

Histotripsy

PROCEDURE

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Colorectal CancerColorectal Cancer (CRC)+5 more

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RECRUITINGNA

Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer

Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy

Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery

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