RecruitingNot ApplicableNCT07428356

Histotripsy for Ablation of Liver Tumours in Asia

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

Sponsor

National Cancer Centre, Singapore

Enrollment

40 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

Liver Malignant Tumors

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.

Eligibility

Min Age: 21 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing histotripsy — a non-invasive ultrasound-based technique that uses focused sound waves to destroy tumour tissue — for treating liver tumours in patients in Asia. It is being studied for patients who cannot have surgery or other standard local treatments. **You may be eligible if...** - You are 21 years old or older - You have a confirmed liver tumour (either primary liver cancer or cancer that has spread to the liver from another organ) - You have up to 3 liver tumours, each no larger than 3 cm - Your tumours can be seen clearly on ultrasound - You are not a candidate for surgery or other standard treatments, or you have limited tumour growth in your liver while receiving systemic therapy **You may NOT be eligible if...** - You have more than 3 liver lesions being targeted - Your tumours are larger than 3 cm - Your tumours cannot be clearly seen on ultrasound - You are in poor general health Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHistotripsy 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.