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Sound waves zap liver tumors in groundbreaking asian trial

NCT ID NCT07428356

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

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

21 to 99 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • National Cancer Centre Singapore

    RECRUITING

    Singapore, 168583, Singapore

  • National University Hospital

    NOT_YET_RECRUITING

    Singapore, 119074, Singapore

  • Singapore General Hospital

    RECRUITING

    Singapore, 169608, Singapore

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