Histotripsy for Colorectal Cancer

(ECHO CRC Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Northwell Health

Must not be taking: Investigational drugs

Disqualifiers: Cardiovascular disease, Active infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 1 week

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how histotripsy affects the immune system in individuals with colorectal cancer that has spread to the liver. Histotripsy, a non-invasive technique, uses ultrasound waves to target and destroy liver tumors. Researchers aim to determine if this treatment alters the behavior of certain immune cells, such as T-cells, after tumor treatment. This study is suitable for individuals diagnosed with colorectal cancer and confirmed liver metastases through imaging tests. As a Phase 1 trial, the research focuses on understanding how this new treatment works in people, offering participants the opportunity to be among the first to receive it.

What prior data suggests that histotripsy is safe for treating liver metastases?

Research has shown that histotripsy is generally safe for treating liver tumors. Studies have found it to be well tolerated with few complications, and serious issues are rare. The FDA has approved this non-invasive treatment for liver tumors, indicating a level of safety confidence.

Histotripsy uses sound waves to break down tumor tissues. In past studies on liver metastases, it primarily affected only the targeted area, which reassures patients considering this treatment.

While the current study is in its early stages and examines histotripsy for colorectal cancer with liver metastases, existing data from other liver tumor cases support its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Histotripsy is unique because it uses sound waves to non-invasively break down liver tumors, including those from colorectal cancer. This method stands out from standard treatments like surgery, chemotherapy, or radiation, as it directly disrupts the tumor's physical structure and may stimulate an immune response. Researchers are excited because histotripsy has the potential to enhance the body's immune system by altering T-cell activity, which could improve responses to other cancer treatments.

What evidence suggests that histotripsy is effective for colorectal cancer with liver metastasis?

Research has shown that histotripsy, a non-invasive treatment, effectively controls liver tumors. Studies found that 94% of tumors were controlled 30 days after treatment, increasing to 96% after 90 days. This indicates that histotripsy can successfully target and destroy liver tumors. Additionally, the FDA has approved histotripsy for treating liver tumors, including those that have spread from colorectal cancer. This trial will investigate the systemic immune response to histotripsy in patients with colorectal cancer with liver metastasis. Although less information exists on its effects on the body's overall immune response, the treatment's ability to break down tumors shows promise for boosting immune activity. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with biopsy-proven metastatic colorectal cancer that has spread to the liver. They must have a measurable liver tumor and be eligible for histotripsy, which is a non-invasive treatment. Participants need normal or near-normal blood counts, liver function, and kidney function (or on dialysis).

Inclusion Criteria

My organs and bone marrow are working well.

Estimated life expectancy of at least 90 days

No restrictions based on race or ethnicity

Exclusion Criteria

I have not had major surgery or significant injury in the last 14 days.

I have not had an infection needing treatment in the last 2 weeks.

Active pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo histotripsy treatment for colorectal cancer liver metastases

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in peripheral T-cell clonal expansion and exhaustion markers

90 days

Blood samples collected at 14, 28, and 90 days post-treatment

Long-term follow-up

Participants are monitored for systemic immune modulation over an extended period

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Histotripsy

Trial Overview

The study tests how histotripsy affects the immune system in patients with colorectal cancer that has spread to the liver. It's not a comparison but an observation of changes in T-cell responses after treatment. Patients will undergo regular blood tests before and after receiving histotripsy.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Citations

1.

fusfoundation.org

fusfoundation.org/posts/histotripsy-for-liver-tumors-one-year-data-suggest-90-tumor-control/

Histotripsy for Liver Tumors: One-Year Data Suggest 90% ...

Overall survival at one year was 73.3% for patients with primary liver cancer, and 48.6% in patients with metastatic disease.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40227626/

Histotripsy of Liver Tumors: Patient Selection, Ethical ...

Colorectal cancer alone results in liver metastases in nearly 50% of patients, with approximately 85% presenting with unresectable disease.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07044362

Study Details | NCT07044362 | Histotripsy Plus ...

This is a prospective trial testing the benefits of histotripsy plus chemotherapy for participants with colorectal liver metastasis. Histotripsy has been ...

4.

michiganmedicine.org

michiganmedicine.org/health-lab/histotripsy-liver-tumor-trial-successful-early-clinical-adoption-recommended

Histotripsy liver tumor trial successful, early clinical adoption ...

Researchers expect these results will lead to early clinical adoption, larger trials, and more detailed data on long term outcomes. Currently ...

5.

ascopubs.org

ascopubs.org/doi/10.1200/OP-25-00550

Local Tumor Control of Liver Tumors After Histotripsy

However, efficacy data are lacking. We note a 94% rate of LTC at 30 days and 96% at 90 days.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41016946/

Histotripsy of Liver Metastases: Short-Term Safety and ...

Conclusion: Histotripsy demonstrates a favorable safety profile for liver metastases. Observed off-target effects in untreated lesions suggest ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1091255X25000599

The first international experience with histotripsy: a safety ...

Histotripsy was well tolerated, with few overall complications and rare serious complications, indicating a safety profile that compares favorably with that of ...