Histotripsy for Ablation of Liver Tumours in Asia
ConditionLiver Malignant Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-99
SponsorNational Cancer Centre, Singapore
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥21 years at the time of consent.
Up to 3 hepatic lesions.
Tumour ≤ 3 cm in longest diameter.
Lesion(s) must be visible and targetable by ultrasound.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Histotripsy using HistoSonics Edison™ System
DeviceThe 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Histotripsy GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months post-procedure.2
Major complication rate.
Incidence of treatment-related adverse events (AEs) of grade ≥3 (CTCAE v5.0) within 30 days post-procedure.
Time frame
30 days post-procedure.Secondary outcomes
1
36-hour technical success rate.
Proportion of patients with tumour treated volume ≥ targeted volume with complete tumour coverage, evaluated using contrast-enhanced MRI/CT.
Time frame
36 hours post-procedure.2
30-day technique efficacy rate.
Proportion of patients with absence of nodular or mass-like enhancement within or along the treatment volume
Time frame
30 days post-procedure.Other outcomes
1
Longitudinal Response Evaluation and patterns of progression.
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
Time frame
3 months, 6 months, 1 year and 2 years post-procedure.2
Changes in quality-of-life post-histotripsy, based on EORTC QLQ-C30 scores.
Change of scores based on EORTC QLQ-C30 for liver malignancies from baseline to each of the timepoints specified in the protocol
Time frame
30 days, 3 months, 6 months, 1 year and 2 years post-procedure.3
Changes in quality-of-life post-histotripsy, based on EORTC QLQ-HCC18 scores.
Change of scores based on EORTC QLQ-HCC18 for liver malignancies from baseline to each of the timepoints specified in the protocol
Time frame
30 days, 3 months, 6 months, 1 year and 2 years post-procedure.4
Immune Response Analysis based on Information from Immune Biomarkers.
Evaluation of changes in circulating immune biomarkers post-histotripsy.
Time frame
36 hours, 14 days, 30 days, 3 months and 6 months post-procedure.Sponsors and contacts
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Source ClinicalTrials.gov