Liver Malignant TumorsHALTNCT07428356
Histotripsy for Ablation of Liver Tumours in Asia
A study testing Histotripsy using HistoSonics Edison™ System in people with Liver Malignant Tumors, run by National Cancer Centre, Singapore at 3 sites in Singapore.
Trial summary
The HALT study aims to evaluate histotripsy in an Asian population for both primary (HCC, CCA) and secondary liver malignancies with liver-limited or oligoprogressive disease. In addition to safety and local control, the study incorporates translational endpoints including immune profiling (PBMCs, cytokines)… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Liver Malignant Tumors
- What is being tested?
- Histotripsy using HistoSonics Edison™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesSingapore
- Study dates
- 7 Nov 2025to 7 May 2029
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥21 years at the time of consent.
- Histologically/cytologically confirmed cancers (imaging diagnosis as per AASLD allowed for HCC):
- Liver limited malignancies (primary or secondary) not eligible for/declined resection or other locoregional treatment modalities.
- All solid cancer patients (e.g., HCC, colorectal, breast, pancreatic cancers etc) undergoing systemic therapy with oligoprogressive liver disease (defined as ≤ 3 liver limited progressive lesions, ≤ 3 cm in maximum diameter having received > 3 months of systemic therapy).
- Characteristics of hepatic lesions intended for treatment:
- Up to 3 hepatic lesions.
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- Tumour ≤ 3 cm in longest diameter.
- Lesion(s) must be visible and targetable by ultrasound.
- ECOG Performance Status 0-1.
- Child-Pugh class A or B7 liver function for patients with underlying cirrhosis.
- Adequate hematologic and organ function within 14 days prior to treatment:
- Haemoglobin ≥ 9.0 g/dL
- Platelets ≥ 75,000/mm³
- INR ≤ 1.5 × ULN
- Estimated (by Cockroft-Gault or Modification of Diet in Renal Disease (MDRD) or measured creatinine clearance ≥ 50ml/min.
- Total bilirubin ≤ 1.5 × upper limit normal or direct bilirubin ≤ ULN for participants with total bilirubin > 1.5 × ULN (participants with known history of elevated indirect bilirubin level suggestive of extrahepatic source of elevation e.g. Gilbert's disease may be recruited with bilirubin levels ≤ 3 × ULN)
- AST and ALT ≤ 5 × ULN
- Ability to undergo general anaesthesia, as confirmed by pre-anaesthetic assessment.
- Life expectancy ≥ 3 months in the opinion of the investigator.
- Willing and able to comply with study visits and procedures.
- Written informed consent obtained prior to any study-related procedures.
Who cannot join
- Extrahepatic disease progression requiring immediate systemic intervention, including new brain metastases or malignant ascites.
- Vascular invasion, defined as gross involvement or encasement of major portal vein or hepatic vein branches.
- Tumours located adjacent (<5 mm) to hollow viscera (e.g., stomach, colon) where histotripsy poses perforation risk.
- Lesions poorly visualized on ultrasound or not targetable due to overlying ribs or gas.
- Severe or uncontrolled comorbidities including:
- Uncontrolled hypertension or cardiovascular disease
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- Active infection (requiring systemic therapy)
- Severe chronic obstructive pulmonary disease or hypoxia
- Contraindications to general anaesthesia or surgery.
- Pregnancy or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment.
- Participation in another interventional trial within 4 weeks prior to enrollment, or concurrent participation in a therapeutic study.
- Any condition that, in the investigator's judgment, may compromise the patient's safety or interfere with protocol adherence.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sandra Hsing contact
Singapore3 sites, 3 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Dr Shao-Jin ONG, MBBS, FRCR (UK), FAMS, shao_jin_ong@nuhs.edu.sg
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
Prof Brian Goh, MBBS, MMed, MSc, FRCSEd, FAMS, +65 63265440, brian.goh@singhealth.com.sg
- Recruiting
Singapore General Hospital
Singapore, 169608
A/Prof Chow Wei TOO, MBBS, FRCR, MMed, FAMS, too.chow.wei@singhealth.com.sg
About this study
Official title: Histotripsy Ablation for Liver Tumours (HALT): A Multi-centre Prospective Pilot Study on the Safety and Efficacy of Histotripsy in Asian Primary and Secondary Liver Malignancies
The HALT study aims to evaluate histotripsy in an Asian population for both primary (HCC, CCA) and secondary liver malignancies with liver-limited or oligoprogressive disease. In addition to safety and local control, the study incorporates translational endpoints including immune profiling (PBMCs, cytokines), microbiome shifts, and optional tumour biopsies. This trial will provide critical data on the feasibility, tolerability, and biological impact of histotripsy in a region with the highest burden of liver cancer.
Read the detailed description
This will be a single-arm, multi-centre, prospective pilot study enrolling patients with:
- Liver limited malignancies (primary or secondary) not eligible for/declined resection or other locoregional treatment modalities.
- All solid cancer patients (e.g., HCC, colorectal, breast, pancreatic cancers etc) undergoing systemic therapy with oligoprogressive liver disease (defined as ≤ 3 liver limited progressive lesions, ≤ 3 cm in maximum diameter having received > 3 months of systemic therapy).
Patients will undergo baseline imaging and laboratory investigations, followed by histotripsy treatment under general anaesthesia. Post-procedure assessments will be performed at predefined intervals for clinical, radiologic, and biomarker evaluation.
- Conditions
- Liver Malignant Tumors
- Being tested
- Histotripsy using HistoSonics Edison™ System
- Keywords
- Histotripsy, Ablation of Liver Tumours
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histotripsy using HistoSonics Edison™ SystemDevice
The histotripsy procedure will be performed using the HistoSonics Edison™ System, an image-guided, non-invasive focused ultrasound platform specifically designed for mechanical tissue fractionation. Key steps include general anaesthesia and positioning, pre-treatment planning and imaging, and histotripsy ablation procedure.
| Study group | Role | What they receive |
|---|---|---|
| Histotripsy Group | Experimental | Histotripsy for Ablation of Liver Tumours. Receives: Device: Histotripsy using HistoSonics Edison™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month local control rate.
Proportion of patients with absence of local tumour progression at the treated site as per RECIST version 1.1 criteria.
Measured: 6 months post-procedure.
Major complication rate.
Incidence of treatment-related adverse events (AEs) of grade ≥3 (CTCAE v5.0) within 30 days post-procedure.
Measured: 30 days post-procedure.
Secondary outcomes (2)
36-hour technical success rate.
Proportion of patients with tumour treated volume ≥ targeted volume with complete tumour coverage, evaluated using contrast-enhanced MRI/CT.
Measured: 36 hours post-procedure.
30-day technique efficacy rate.
Proportion of patients with absence of nodular or mass-like enhancement within or along the treatment volume
Measured: 30 days post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start7 Nov 2025
- Primary completion7 Nov 2027 (estimated)
- Study completion7 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Malignant TumorsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Histotripsy treatment.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Brian Goh, MBBS, MMed, MSc, FRCSEd, FAMS, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428356
- Sponsor's protocol ID
- 2025-0635
- Acronym
- HALT
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histotripsy Ablation for Liver Tumours (HALT): A Multi-centre Prospective Pilot Study on the Safety and Efficacy of Histotripsy in Asian Primary and Secondary Liver Malignancies
- ClinicalTrials.gov ID
- NCT07428356
- Acronym / sponsor ID
- HALT / 2025-0635
- Conditions
- Liver Malignant Tumors
- Keywords
- Histotripsy, Ablation of Liver Tumours
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 7 Nov 2027 (estimated)
- Study completion
- 7 May 2029 (estimated)
- First posted
- 23 Feb 2026 (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 HALT study aims to evaluate histotripsy in an Asian population for both primary (HCC, CCA) and secondary liver malignancies with liver-limited or oligoprogressive disease. In addition to safety and local control, the study incorporates translational endpoints including immune profiling (PBMCs, cytokines), microbiome shifts, and optional tumour biopsies. This trial will provide critical data on the feasibility, tolerability, and biological impact of histotripsy in a region with the highest burden of liver cancer.
Detailed description
This will be a single-arm, multi-centre, prospective pilot study enrolling patients with:
- Liver limited malignancies (primary or secondary) not eligible for/declined resection or other locoregional treatment modalities.
- All solid cancer patients (e.g., HCC, colorectal, breast, pancreatic cancers etc) undergoing systemic therapy with oligoprogressive liver disease (defined as ≤ 3 liver limited progressive lesions, ≤ 3 cm in maximum diameter having received > 3 months of systemic therapy).
Patients will undergo baseline imaging and laboratory investigations, followed by histotripsy treatment under general anaesthesia. Post-procedure assessments will be performed at predefined intervals for clinical, radiologic, and biomarker evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Histotripsy treatment.
| Arm | Type | Receives |
|---|---|---|
| Histotripsy Group | Experimental | Device: Histotripsy using HistoSonics Edison™ SystemHistotripsy for Ablation of Liver Tumours. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age ≥21 years at the time of consent.
- Histologically/cytologically confirmed cancers (imaging diagnosis as per AASLD allowed for HCC):
- Characteristics of hepatic lesions intended for treatment:
- ECOG Performance Status 0-1.
- Child-Pugh class A or B7 liver function for patients with underlying cirrhosis.
Key exclusion criteria (12 listed)
- Extrahepatic disease progression requiring immediate systemic intervention, including new brain metastases or malignant ascites.
- Vascular invasion, defined as gross involvement or encasement of major portal vein or hepatic vein branches.
- Tumours located adjacent (<5 mm) to hollow viscera (e.g., stomach, colon) where histotripsy poses perforation risk.
- Lesions poorly visualized on ultrasound or not targetable due to overlying ribs or gas.
- Severe or uncontrolled comorbidities including:
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 |
|---|---|---|
| Histotripsy using HistoSonics Edison™ SystemThe histotripsy procedure will be performed using the HistoSonics Edison™ System, an image-guided, non-invasive focused ultrasound platform specifically designed for mechanical tissue fractionation. Key steps include general anaesthesia and positioning, pre-treatment planning and imaging, and histotripsy ablation procedure. | Device | Histotripsy Group |
Primary outcome
6-month local control rate.
Time frame: 6 months post-procedure.
Proportion of patients with absence of local tumour progression at the treated site as per RECIST version 1.1 criteria.
Major complication rate.
Time frame: 30 days post-procedure.
Incidence of treatment-related adverse events (AEs) of grade ≥3 (CTCAE v5.0) within 30 days post-procedure.
2 secondary outcomes
36-hour technical success rate.
Time frame: 36 hours post-procedure.
30-day technique efficacy rate.
Time frame: 30 days post-procedure.
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 8 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Sandra Hsing contact
Prof Brian Goh, MBBS, MMed, MSc, FRCSEd, FAMS principal investigator
National Cancer Centre, Singapore
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Histotripsy using HistoSonics Edison™ System in people with Liver Malignant Tumors, run by National Cancer Centre, Singapore at 3 sites in Singapore.
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 21 inclusion and 12 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. 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 Prof Brian Goh, MBBS, MMed, MSc, FRCSEd, FAMS (+65 63265440, brian.goh@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month local control rate. (time frame: 6 months post-procedure.). The study lists 2 primary outcomes in all. 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 8 Oct 2026.