Histotripsy for Ablation of Liver Tumours in Asia (HALT)

February 19, 2026 updated by: National Cancer Centre, Singapore

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be a single-arm, multi-centre, prospective pilot study enrolling patients with:

A) Liver limited malignancies (primary or secondary) not eligible for/declined resection or other locoregional treatment modalities.

B) 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
      • Singapore, Singapore, 119074
        • Not yet recruiting
        • National University Hospital
        • Contact:
      • Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥21 years at the time of consent.

  2. Histologically/cytologically confirmed cancers (imaging diagnosis as per AASLD allowed for HCC):

    A) Liver limited malignancies (primary or secondary) not eligible for/declined resection or other locoregional treatment modalities.

    B) 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).

  3. Characteristics of hepatic lesions intended for treatment:

    • Up to 3 hepatic lesions.
    • Tumour ≤ 3 cm in longest diameter.
    • Lesion(s) must be visible and targetable by ultrasound.
  4. ECOG Performance Status 0-1.
  5. Child-Pugh class A or B7 liver function for patients with underlying cirrhosis.

  6. 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
  7. Ability to undergo general anaesthesia, as confirmed by pre-anaesthetic assessment.
  8. Life expectancy ≥ 3 months in the opinion of the investigator.
  9. Willing and able to comply with study visits and procedures.
  10. Written informed consent obtained prior to any study-related procedures.

Exclusion Criteria:

  1. Extrahepatic disease progression requiring immediate systemic intervention, including new brain metastases or malignant ascites.
  2. Vascular invasion, defined as gross involvement or encasement of major portal vein or hepatic vein branches.
  3. Tumours located adjacent (<5 mm) to hollow viscera (e.g., stomach, colon) where histotripsy poses perforation risk.
  4. Lesions poorly visualized on ultrasound or not targetable due to overlying ribs or gas.

  5. Severe or uncontrolled comorbidities including:

    • Uncontrolled hypertension or cardiovascular disease
    • Active infection (requiring systemic therapy)
    • Severe chronic obstructive pulmonary disease or hypoxia
  6. Contraindications to general anaesthesia or surgery.
  7. Pregnancy or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment.
  8. Participation in another interventional trial within 4 weeks prior to enrollment, or concurrent participation in a therapeutic study.
  9. Any condition that, in the investigator's judgment, may compromise the patient's safety or interfere with protocol adherence.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Histotripsy Group
Histotripsy for Ablation of Liver Tumours.
Device: Histotripsy using HistoSonics Edison™ System
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months post-procedure.
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.
30 days post-procedure.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
36-hour technical success rate.
Time Frame: 36 hours post-procedure.
Proportion of patients with tumour treated volume ≥ targeted volume with complete tumour coverage, evaluated using contrast-enhanced MRI/CT.
36 hours post-procedure.
30-day technique efficacy rate.
Time Frame: 30 days post-procedure.
Proportion of patients with absence of nodular or mass-like enhancement within or along the treatment volume
30 days post-procedure.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Longitudinal Response Evaluation and patterns of progression.
Time Frame: 3 months, 6 months, 1 year and 2 years post-procedure.
Percentage change of tumour sizes from baseline to each of the timepoints specified in the protocol. Pattern of progression will be tabulation (frequency + percentages) of the pattern of progression
3 months, 6 months, 1 year and 2 years post-procedure.
Changes in quality-of-life post-histotripsy, based on EORTC QLQ-C30 scores.
Time Frame: 30 days, 3 months, 6 months, 1 year and 2 years post-procedure.
Change of scores based on EORTC QLQ-C30 for liver malignancies from baseline to each of the timepoints specified in the protocol
30 days, 3 months, 6 months, 1 year and 2 years post-procedure.
Changes in quality-of-life post-histotripsy, based on EORTC QLQ-HCC18 scores.
Time Frame: 30 days, 3 months, 6 months, 1 year and 2 years post-procedure.
Change of scores based on EORTC QLQ-HCC18 for liver malignancies from baseline to each of the timepoints specified in the protocol
30 days, 3 months, 6 months, 1 year and 2 years post-procedure.
Immune Response Analysis based on Information from Immune Biomarkers.
Time Frame: 36 hours, 14 days, 30 days, 3 months and 6 months post-procedure.
Evaluation of changes in circulating immune biomarkers post-histotripsy.
36 hours, 14 days, 30 days, 3 months and 6 months post-procedure.
Immune Response Analysis based on Information from Microbiome.
Time Frame: 36 hours, 14 days, 30 days, 3 months and 6 months post-procedure.
Evaluation of changes in circulating microbiome post-histotripsy.
36 hours, 14 days, 30 days, 3 months and 6 months post-procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Centre, Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Prof Brian Goh, MBBS, MMed, MSc, FRCSEd, FAMS, National Cancer Centre, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 7, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 7, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-0635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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