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New treatment option for Liver Malignant Tumors
Official title Histotripsy for Ablation of Liver Tumours in Asia
ClinicalTrials.gov ID: NCT07428356
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 99
You may be able to join if
- Age ≥21 years at the time of consent.
- Histologically/cytologically confirmed cancers (imaging diagnosis as per AASLD allowed for HCC): A) Liver limited malignancies (primary or secondary)...
- Characteristics of hepatic lesions intended for treatment:
- Up to 3 hepatic lesions.
- Tumour ≤ 3 cm in longest diameter.
You likely can't join if
- 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.
- Severe or uncontrolled comorbidities including:
- Uncontrolled hypertension or cardiovascular disease
See the full eligibility criteria
- Age ≥21 years at the time of consent.
- Histologically/cytologically confirmed cancers (imaging diagnosis as per AASLD allowed for HCC): A) Liver limited malignancies (primary or secondary) not eligible for/declined resection or other locoregional treatment...
- 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.
- ECOG Performance Status 0-1.
- Child-Pugh class A or B7 liver function for patients with underlying cirrhosis.
- 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...
- AST and ALT ≤ 5 × ULN
- Ability to undergo general anaesthesia, as confirmed by pre-anaesthetic assessment.
- Life expectancy ≥ 3 months in the opinion of the investigator.
- Willing and able to comply with study visits and procedures.
- Written informed consent obtained prior to any study-related procedures.
- 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.
- Severe or uncontrolled comorbidities including:
- Uncontrolled hypertension or cardiovascular disease
- Active infection (requiring systemic therapy)
- Severe chronic obstructive pulmonary disease or hypoxia
- Contraindications to general anaesthesia or surgery.
- Pregnancy or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment.
- Participation in another treatment trial within 4 weeks prior to enrollment, or concurrent participation in a therapeutic study.
- Any condition that, in the investigator's judgment, may compromise the patient's safety or interfere with protocol adherence.
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.