Histotripsy for Ablation of Liver Tumours in Asia

Exclusion Criteria

• •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).
• •3. Characteristics of hepatic lesions intended for treatment:
• •* Up to 3 hepatic lesions.
• •* Tumour ≤ 3 cm in longest diameter.
• •* Lesion(s) must be visible and targetable by ultrasound.
• •4. ECOG Performance Status 0-1.
• •5. Child-Pugh class A or B7 liver function for patients with underlying cirrhosis.
• •6. Adequate hematologic and organ function within 14 days prior to treatment:
• •* Haemoglobin ≥ 9.0 g/dL
• •* Platelets ≥ 75,000/mm³
• •* INR ≤ 1.5 × ULN
• •* Estimated (by Cockroft-Gault or Modification of Diet in Renal Disease (MDRD) or measured creatinine clearance ≥ 50ml/min.
• •* Total bilirubin ≤ 1.5 × upper limit normal or direct bilirubin ≤ ULN for participants with total bilirubin \> 1.5 × ULN (participants with known history of elevated indirect bilirubin level suggestive of extrahepatic source of elevation e.g. Gilbert's disease may be recruited with bilirubin levels ≤ 3 × ULN)
• •* AST and ALT ≤ 5 × ULN
• •7. Ability to undergo general anaesthesia, as confirmed by pre-anaesthetic assessment.
• •8. Life expectancy ≥ 3 months in the opinion of the investigator.
• •9. Willing and able to comply with study visits and procedures.
• •10. Written informed consent obtained prior to any study-related procedures.
• •1. Extrahepatic disease progression requiring immediate systemic intervention, including new brain metastases or malignant ascites.
• •2. Vascular invasion, defined as gross involvement or encasement of major portal vein or hepatic vein branches.
• •3. Tumours located adjacent (\<5 mm) to hollow viscera (e.g., stomach, colon) where histotripsy poses perforation risk.
• •4. Lesions poorly visualized on ultrasound or not targetable due to overlying ribs or gas.
• •5. Severe or uncontrolled comorbidities including:
• •* Uncontrolled hypertension or cardiovascular disease
• •* Active infection (requiring systemic therapy)
• •* Severe chronic obstructive pulmonary disease or hypoxia
• •6. Contraindications to general anaesthesia or surgery.
• •7. Pregnancy or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment.
• •8. Participation in another interventional trial within 4 weeks prior to enrollment, or concurrent participation in a therapeutic study.
• •9. Any condition that, in the investigator's judgment, may compromise the patient's safety or interfere with protocol adherence.