Sound waves zap liver tumors in groundbreaking asian trial
NCT ID NCT07428356
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests histotripsy, a non-invasive treatment that uses focused ultrasound to destroy liver tumors without needles or surgery. It involves 40 adults with liver cancer who cannot have surgery or other standard treatments. The goal is to see if it is safe and effective at controlling tumor growth.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥21 years at the time of consent. 2. 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 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). 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. Exclusion Criteria: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Cancer Centre Singapore
RECRUITINGSingapore, 168583, Singapore
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National University Hospital
NOT_YET_RECRUITINGSingapore, 119074, Singapore
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Singapore General Hospital
RECRUITINGSingapore, 169608, Singapore
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