NCT07428356

Brief 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), 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
32mo left

Started Nov 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Nov 2025May 2029

Study Start

First participant enrolled

November 7, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2027

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2029

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 6, 2026

Last Update Submit

February 19, 2026

Conditions

Liver Malignant Tumors

Keywords

HistotripsyAblation of Liver Tumours

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    30 days post-procedure.

Secondary Outcomes (2)

  • 36-hour technical success rate.

    36 hours post-procedure.

  • 30-day technique efficacy rate.

    30 days post-procedure.

Other Outcomes (5)

  • Longitudinal Response Evaluation and patterns 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.

    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.

    30 days, 3 months, 6 months, 1 year and 2 years post-procedure.

  • +2 more other outcomes

Study Arms (1)

Histotripsy Group

EXPERIMENTAL

Histotripsy for Ablation of Liver Tumours.

Device: Histotripsy using HistoSonics Edison™ System

Interventions

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.

Histotripsy Group

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥21 years at the time of consent.
  • 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).
  • 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.
  • 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.
  • +6 more criteria

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National University Hospital

Singapore, 119074, Singapore

NOT YET RECRUITING

National Cancer Centre Singapore

Singapore, 168583, Singapore

RECRUITING

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Prof Brian Goh, MBBS, MMed, MSc, FRCSEd, FAMS

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof Brian Goh, MBBS, MMed, MSc, FRCSEd, FAMS

CONTACT

+65 63265440brian.goh@singhealth.com.sg

Sandra Hsing

CONTACT

sandra.hsing.san@nccs.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Patients will undergo baseline imaging and laboratory investigations, followed by histotripsy treatment under general anaesthesia.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Histotripsy treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 23, 2026

Study Start

November 7, 2025

Primary Completion (Estimated)

November 7, 2027

Study Completion (Estimated)

May 7, 2029

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

SG(3)