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NCT Number: NCT07044362

Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

The goal of this clinical trial is to learn if histotripsy plus chemotherapy works to treat unresectable, bilobar liver- confined colorectal cancer liver metastasis (CRLM). The main question this clinical trial aims to answer is:

• Does the management of this condition with uninterrupted palliative chemotherapy and histotripsy demonstrate improved progression-free survival?

Participants will:

* Receive chemotherapy treatment per standard procedure. * Undergo histotripsy treatment according to current standard procedures at Cleveland Clinic. * Occasionally receive Computerized Tomography (CT) scan with and without contrast, give biopsy of treated and untreated liver lesions, and participate in a blood draw of up to 3 teaspoons at each in-person visit. * Participate in genetic testing, as a part of the standard of care for the treatment.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Cancer Liver Diseases Liver Metastases Liver Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Federico Aucejo, MD

CONTACT

About this study

This is a prospective trial testing the benefits of histotripsy plus chemotherapy for participants with colorectal liver metastasis. Histotripsy has been approved by the FDA with De Novo classification for non-invasive destruction of liver tumors. Up to 100 participants with colorectal cancer liver metastasis will be included.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with liver-confined colorectal cancer liver metastasis (CRLM) or participants who have low-volume pulmonary disease along with CRLM
  • Participants receiving first line therapy with base of 5-FU with either oxaliplatin or irinotecan, or who are within 3 months of beginning chemotherapy, or participants who have completed chemotherapy treatment within 1 month of the histotripsy evaluation
  • Participants who have undergone other liver-directed therapy, such as ablation, embolization
  • Participants with multiple unresectable metastases that cannot be completely treated with resection and/or ablation
  • Participants aged ≥18 years

Exclusion criteria

  • Participants with resectable disease
  • Participants with non-pulmonary extra-hepatic disease including but not limited to bone or peritoneal metastasis.
  • Participants who are not able to tolerate general anesthesia
  • Participants who have Childs C Cirrhosis
  • Other non-skin malignancy within 2 years of study
  • WBC count < 3,000 /uL
  • Absolute Neutrophil Count < 1,500 /uL
  • History of Non-malignant serious concurrent illness that would increase the risk of histotripsy
  • Participants with MSI-High
  • Participants aged < 18 years
  • Pregnant participants

Treatment and study plan

HistoSonics Edison® System

Device

Histotripsy is a novel, totally non-invasive, non-ionizing, and non-thermal ablation technique that mechanically disrupts tumors through precisely controlled acoustic cavitation. Histotripsy is administered via HistoSonics Edison® System.

Chemotherapy

Drug

Chemotherapy (standard of care with first line therapy of base of 5-FU with either oxaliplatin or irinotecan).

Primary outcomes

  1. Radiologic tumor viability

    Time frame: 90 days post-treatment

    As assessed by the degree of short-term local tumor control in Colorectal Liver Metastasis(CRLM)

Secondary outcomes

  1. Rate of Tumor Necrosis

    Time frame: 30 days post-treatment

    Biopsy results will be used to assess the degree of tumor necrosis in treated lesions.

  2. Percentage of Viable Tumor in Lesion

    Time frame: 30 days post-treatment

    Biopsy results will be used to assess the percentage of lesions that have viable tumor.

  3. Infiltration of CD4

    Time frame: 30 days post-treatment

    Biopsy results will be used to assess the infiltration of CD4.

  4. Infiltration of CD8

    Time frame: Baseline, 30 days post-treatment

    Biopsy results will be used to assess the infiltration of CD8.

  5. Infiltration of B-cells

    Time frame: 30 days post- treatment

    Biopsy results will be used to assess the infiltration of B-cells.

  6. Infiltration of CD45

    Time frame: 30 days post-treatment

    Biopsy results will be used to assess the infiltration of CD45.

  7. Infiltration of CD68

    Time frame: 30 days post-treatment

    Biopsy results will be used to assess the infiltration of CD68.

  8. Infiltration of PD-1

    Time frame: 30 days post-treatment

    Biopsy results will be used to assess the infiltration of PD-1.

  9. Infiltration of PD-L1

    Time frame: 30 days after treatment

    Biopsy results will be used to assess the infiltration of PD-L1.

  10. Infiltration of CTLA-4

    Time frame: 30 days post-treatment

    Biopsy results will be used to assess the infiltration of CTLA-4.

  11. Overall Survival

    Time frame: Up to 24 months post-treatment

    Median overall survival will be measured up to 2 years post treatment.

  12. Progression Free Survival (PFS)

    Time frame: Up to 24 months post-treatment

    The rate of progression free survival will be measured up to 2 years post treatment.

  13. 30 day Complications

    Time frame: 30 days post-treatment

    The safety profile of the treatment, as measured by the complications at 30 days.

  14. 90 day Complications

    Time frame: 90 days post-treatment

    The safety profile of the treatment, as measured by the complications at 90 days.

Study contacts

Contact information is provided by the study sponsor or research team.

Erlind Allkushi

CONTACT

[email protected]

216-444-0223

Federico Aucejo, MD

CONTACT

[email protected]

216-445-7159

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • HistoSonics, Inc.

Registry information

Official study title

Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jun 30, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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