Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

NCT07044362 | Recruiting DMC FDA Device

• 1 other identifier: CASE6224
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Liver Metastases; Liver Cancer

Keywords

Histotripsy; Liver-confined; Liver colorectal cancer liver metastasis; Liver-confined colorectal cancer liver metastasis; Chemotherapy; Advanced Colorectal; Advanced Colorectal Liver Metastasis

Outcome Measures

Primary Outcomes (1)

• Radiologic tumor viability

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

  90 days post-treatment

Secondary Outcomes (14)

• Rate of Tumor Necrosis

  30 days post-treatment

• Percentage of Viable Tumor in Lesion

  30 days post-treatment

• Infiltration of CD4

  30 days post-treatment

• Infiltration of CD8

  Baseline, 30 days post-treatment

• Infiltration of B-cells

  30 days post- treatment

Study Arms (1)

Histotripsy + Chemotherapy

EXPERIMENTAL

All enrolled participants will undergo combined treatment with Histotripsy and chemotherapy without interruption in the chemotherapy.

Device: HistoSonics Edison® System; Drug: Chemotherapy

Interventions

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.

Histotripsy + Chemotherapy

Chemotherapy DRUG

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

Histotripsy + Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• HistoSonics, Inc.: collaborator

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Liver Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Federico Aucejo, MD

  Cleveland Clinic, Digestive Disease Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Aucejo, MD

CONTACT

216-445-7159; Aucejof@ccf.org

Erlind Allkushi

CONTACT

216-444-0223; ALLKUSE2@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single arm, prospective, non-randomized trial.

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: June 30, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)