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.
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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
National University Hospital
Singapore, Singapore
NOT_YET_RECRUITINGNational Cancer Centre Singapore
Singapore, Singapore
RECRUITINGSingapore General Hospital
Singapore, Singapore
RECRUITING6-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.
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.
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.
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.
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