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
Qualifiers
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
Treatments tested in this trial
- Histotripsy using HistoSonics Edison™ System
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov