NCT07428356

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Liver Malignant Tumors

Interventions

Type	Name	Description
DEVICE	Histotripsy 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.

Timeline

• Start date: 2025-11-07
• Primary completion: 2027-11-07
• Completion: 2029-05-07
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

3 sites across 1 country: Singapore

Regulatory

• FDA-regulated device study