Colorectal CancerNCT07044362
Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis
A study testing HistoSonics Edison® System and Chemotherapy in people with Colorectal Cancer and Liver Metastases, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Liver Metastases, Liver Cancer
- What is being tested?
- HistoSonics Edison® System and Chemotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Federico Aucejo, MD
About this study
Official title: Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer, Liver Metastases, Liver Cancer
- Being tested
- HistoSonics Edison® System, Chemotherapy
- Keywords
- Histotripsy, Liver-confined, Liver colorectal cancer liver metastasis, Liver-confined colorectal cancer liver metastasis, Chemotherapy, Advanced Colorectal, Advanced Colorectal Liver Metastasis
- Medical subject headings
- Colorectal Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistoSonics Edison® SystemDevice
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.
ChemotherapyDrug
Chemotherapy (standard of care with first line therapy of base of 5-FU with either oxaliplatin or irinotecan).
| Study group | Role | What they receive |
|---|---|---|
| Histotripsy + Chemotherapy | Experimental | All enrolled participants will undergo combined treatment with Histotripsy and chemotherapy without interruption in the chemotherapy. Receives: Device: HistoSonics Edison® System; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologic tumor viability
As assessed by the degree of short-term local tumor control in Colorectal Liver Metastasis(CRLM)
Measured: 90 days post-treatment
Secondary outcomes (14)
Rate of Tumor Necrosis
Biopsy results will be used to assess the degree of tumor necrosis in treated lesions.
Measured: 30 days post-treatment
Percentage of Viable Tumor in Lesion
Biopsy results will be used to assess the percentage of lesions that have viable tumor.
Measured: 30 days post-treatment
Infiltration of CD4
Biopsy results will be used to assess the infiltration of CD4.
Measured: 30 days post-treatment
Infiltration of CD8
Biopsy results will be used to assess the infiltration of CD8.
Measured: Baseline, 30 days post-treatment
Infiltration of B-cells
Biopsy results will be used to assess the infiltration of B-cells.
Measured: 30 days post- treatment
Infiltration of CD45
Biopsy results will be used to assess the infiltration of CD45.
Measured: 30 days post-treatment
Infiltration of CD68
Biopsy results will be used to assess the infiltration of CD68.
Measured: 30 days post-treatment
Infiltration of PD-1
Biopsy results will be used to assess the infiltration of PD-1.
Measured: 30 days post-treatment
Infiltration of PD-L1
Biopsy results will be used to assess the infiltration of PD-L1.
Measured: 30 days after treatment
Infiltration of CTLA-4
Biopsy results will be used to assess the infiltration of CTLA-4.
Measured: 30 days post-treatment
Overall Survival
Median overall survival will be measured up to 2 years post treatment.
Measured: Up to 24 months post-treatment
Progression Free Survival (PFS)
The rate of progression free survival will be measured up to 2 years post treatment.
Measured: Up to 24 months post-treatment
30 day Complications
The safety profile of the treatment, as measured by the complications at 30 days.
Measured: 30 days post-treatment
90 day Complications
The safety profile of the treatment, as measured by the complications at 90 days.
Measured: 90 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2025
- Study start19 Nov 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm, prospective, non-randomized trial.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- HistoSonics, Inc.
- Responsible party
- Sponsor
- Investigators
- Federico Aucejo, MD, Principal investigator, Cleveland Clinic, Digestive Disease Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044362
- Sponsor's protocol ID
- CASE6224
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no need for sharing IPD for this clinical trial.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial
- ClinicalTrials.gov ID
- NCT07044362
- Acronym / sponsor ID
- CASE6224
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- HistoSonics, Inc.
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 30 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm, prospective, non-randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Histotripsy + Chemotherapy | Experimental | Device: HistoSonics Edison® System, Drug: ChemotherapyAll enrolled participants will undergo combined treatment with Histotripsy and chemotherapy without interruption in the chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HistoSonics Edison® SystemHistotripsy 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. | Device | Histotripsy + Chemotherapy |
| ChemotherapyChemotherapy (standard of care with first line therapy of base of 5-FU with either oxaliplatin or irinotecan). | Drug | Histotripsy + Chemotherapy |
Primary outcome
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)
14 secondary outcomes
Rate of Tumor Necrosis
Time frame: 30 days post-treatment
Percentage of Viable Tumor in Lesion
Time frame: 30 days post-treatment
Infiltration of CD4
Time frame: 30 days post-treatment
Infiltration of CD8
Time frame: Baseline, 30 days post-treatment
Infiltration of B-cells
Time frame: 30 days post- treatment
Infiltration of CD45
Time frame: 30 days post-treatment
Infiltration of CD68
Time frame: 30 days post-treatment
Infiltration of PD-1
Time frame: 30 days post-treatment
Infiltration of PD-L1
Time frame: 30 days after treatment
Infiltration of CTLA-4
Time frame: 30 days post-treatment
Overall Survival
Time frame: Up to 24 months post-treatment
Progression Free Survival (PFS)
Time frame: Up to 24 months post-treatment
30 day Complications
Time frame: 30 days post-treatment
90 day Complications
Time frame: 90 days post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. There is no need for sharing IPD for this clinical trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Federico Aucejo, MD principal investigator
Cleveland Clinic, Digestive Disease Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HistoSonics Edison® System and Chemotherapy in people with Colorectal Cancer and Liver Metastases, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federico Aucejo, MD (216-445-7159, Aucejof@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiologic tumor viability (time frame: 90 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.