Actively Recruiting

Phase Not Applicable
Age: 21Years - 99Years
All Genders
NCT07428356

Histotripsy for Ablation of Liver Tumours in Asia

Led by National Cancer Centre, Singapore · Updated on 2026-02-23

40

Participants Needed

3

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Histotripsy for Ablation of Liver Tumours in Asia

Who Can Participate

Age: 21Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 years or older at the time of consent
  • Histologically or cytologically confirmed primary or secondary liver cancers, including imaging diagnosis for HCC
  • Liver-limited malignancies not eligible for or declined surgery or other local treatments
  • Patients with solid cancers on systemic therapy having up to 3 progressive liver lesions no larger than 3 cm
  • Up to 3 hepatic lesions visible and targetable by ultrasound
  • ECOG Performance Status of 0 or 1
  • Child-Pugh class A or B7 liver function for patients with cirrhosis
  • Adequate blood counts and organ function within 14 days before treatment
  • Ability to undergo general anesthesia as confirmed by pre-anaesthetic assessment
  • Life expectancy of at least 3 months
  • Willing and able to comply with study visits and procedures
  • Provided written informed consent prior to study procedures
Not Eligible

You will not qualify if you...

  • Extrahepatic disease progression needing immediate systemic treatment, including brain metastases or malignant ascites
  • Vascular invasion involving major portal or hepatic veins
  • Tumors located within 5 mm of hollow organs where treatment risk is high
  • Lesions not well seen or reachable by ultrasound due to ribs or gas
  • Severe or uncontrolled medical conditions like hypertension, cardiovascular disease, active infection, or severe lung disease
  • Contraindications to general anesthesia 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 or therapeutic trial within 4 weeks before enrollment
  • Any condition that may affect patient safety or study adherence as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

National University Hospital

Singapore, Singapore, 119074

Not Yet Recruiting

2

National Cancer Centre Singapore

Singapore, Singapore, 168583

Actively Recruiting

3

Singapore General Hospital

Singapore, Singapore, 169608

Actively Recruiting

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Research Team

P

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

CONTACT

S

Sandra Hsing

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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