Liver TumorsNCT07063771
Safety and Clinical Efficacy of Histotripsy for Liver Cancers Adjacent to Major Intrahepatic Vessels
A study testing Histotripsy in people with Liver Tumors, run by National Taiwan University Hospital.
Trial summary
Malignant liver tumors are among the most common malignancies worldwide, with over 10,000 new cases diagnosed annually in Taiwan. Despite the variety of treatment options currently available for malignant liver tumors, the prognosis for patients with primary hepatocellular carcinoma or metastatic liver cancer remains… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Tumors
- What is being tested?
- Histotripsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages Eligible for Study: 18 Years and older
- Diagnosed with a malignant liver tumor at National Taiwan University Hospital. The diagnosis of liver cancer was based on the international diagnostic criteria of the AASLD, while the diagnosis of other primary malignant liver tumors and metastatic liver tumor was based on pathological diagnostic standards
- Unsuitable for surgical resection. the tumor is located less than 1 cm from critical vascular structures, including the inferior vena cava, hepatic veins, and both main branches of the portal vein.
- Have at least one, but less than or equal to 3 tumors, At least one of them met the third criterion
- Each tumor must be ≤ 5 cm in diameter,
- Child-Pugh class A-B,
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- Eastern Cooperative Oncology Group (ECOG) score of 0-1,
- American Society of Anesthesiologists (ASA) score ≤ 3,
- Adequate bone marrow and liver function (1). Platelet count ≥ 100 K/Μl(2). Total bilirubin ≦ 2.5 mg/dL(3). ALT and AST < 5 x upper limit of normal (4). PT-INR ≦ 2.0.
- Prior Informed Consent Form
- Life expectancy of at least 3 months.
- Maximum tumor depth ≤14 cm from the skin surface
- Patients who are in good physical condition and able to tolerate endotracheal intubation and general anesthesia
Who cannot join
- Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
- Received treatment with an investigational agent/ procedure within 30 days prior to Histotripsy treatment
- Acute infection or inflammation, acute and severe dysfunction of heart, liver and kidney.
- Known history of HIV infection
- Tumor not clearly visualized on ultrasound
- No safe ultrasound pathway due to scarring, bowel gas, calcified tumor, or bone interference
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- Prior radiotherapy within 30 days before or after treatment
- Arterial calcification in the treatment area
- Investigator-assessed contraindications
- Inability to undergo CT/MRI imaging
- Severe anesthesia intolerance
- Tumor invasion of major vessels, gastrointestinal tract, or respiratory tract
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Safety and Efficacy of Irreversible Electroporation for the Treatment of Perivascular Liver Cancers
Malignant liver tumors are among the most common malignancies worldwide, with over 10,000 new cases diagnosed annually in Taiwan. Despite the variety of treatment options currently available for malignant liver tumors, the prognosis for patients with primary hepatocellular carcinoma or metastatic liver cancer remains disheartening. More than 8,000 people die from the disease each year. The majority of patients (approximately 70% to 85%) are diagnosed at an advanced stage or have tumors that are unresectable. In contrast, patients with smaller tumors have a much better chance of achieving a cure. Numerous studies have reported that patients who undergo hepatic lobectomy have a 5-year disease-free survival rate exceeding 50%. For tumors that are not surgically resectable, local ablation techniques such as Radiofrequency Ablation (RFA) have emerged as potentially curative alternatives. However, RFA has significant drawbacks: its percutaneous invasiveness can sometimes lead to bleeding or tumor seeding along the needle tract, and it may be less effective near blood vessels due to the heat-sink effect. Therefore, its application is currently limited to small liver tumors. Histotripsy is a tumor ablation technique developed in recent years that allows for non-invasive treatment of solid tumors using High-Intensity Focused Ultrasound (HIFU). This method works by physically focusing ultrasound energy at a single point within biological tissue, creating a focal zone of high-power, low-frequency ultrasound that induces mechanical fragmentation (histotripsy) and cavitation effects, dissolving the tissue into fragments and destroying tumor cells. Under real-time ultrasound imaging guidance, various scanning treatment protocols are used to move the focal point throughout the treatment zone, effectively ablating the tumor tissue. This clinical trial utilizes the Edison System, developed by HistoSonics Inc. (USA). The first multicenter Phase I human trial of this technology was conducted in 2018, lasting eight weeks and treating 11 patients with advanced, unresectable multifocal liver tumors. All targeted tumors were successfully ablated with no device-related adverse events. This research project aims to evaluate the clinical feasibility and advantages of this system in malignant liver tumor patients who are ineligible for surgical resection but are still candidates for local tumor ablation. To investigators plan to perform ablation under general anesthesia on 20 participants with liver tumors located within 1 cm of the inferior vena cava, hepatic veins, or bilateral portal vein trunks. Post-procedural complications will be monitored, and follow-up over 12 months will assess complete tumor ablation and intrahepatic recurrence to verify the system's clinical viability and potential benefits.
- Conditions
- Liver Tumors
- Being tested
- Histotripsy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistotripsyDevice
Histotripsy is a tumor ablation technique developed in recent years that allows for non-invasive treatment of solid tumors using High-Intensity Focused Ultrasound (HIFU). This method works by physically focusing ultrasound energy at a single point within biological tissue, creating a focal zone of high-power, low-frequency ultrasound that induces mechanical fragmentation (histotripsy) and cavitation effects, dissolving the tissue into fragments and destroying tumor cells. Under real-time ultrasound imaging guidance, various scanning treatment protocols are used to move the focal point throughout the treatment zone, effectively ablating the tumor tissue. The destroyed tumor tissue is gradually absorbed by the body. Since this technique does not require needle puncture, electrode insertion, radiation, or thermal effects, it is minimally invasive and holds the potential to overcome the limitations of existing ablation technologies.
| Study group | Role | What they receive |
|---|---|---|
| treatment liver tumors | Experimental | Not described Receives: Device: Histotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of SF-36 and VAS with preoperative baseline within six months
The main goals are to confirm if the quality of life of subjects improves after treatment with a focused ultrasound system and to assess the safety of the treatment. The acceptable safety range, according to CTCAE Version 5.0 criteria, should be Grade 3 or below.
Measured: six months
Secondary outcomes (1)
Comparison of Tumor Volume Before and After Treatment
Using CT/MRI images to assess changes in tumor volume before and after focused ultrasound treatment, and the RECIST (Response Evaluation Criteria in Solid Tumors) criteria are commonly applied.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumorsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063771
- Sponsor's protocol ID
- 202504040DIPB
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Irreversible Electroporation for the Treatment of Perivascular Liver Cancers
- ClinicalTrials.gov ID
- NCT07063771
- Acronym / sponsor ID
- 202504040DIPB
- Conditions
- Liver Tumors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malignant liver tumors are among the most common malignancies worldwide, with over 10,000 new cases diagnosed annually in Taiwan. Despite the variety of treatment options currently available for malignant liver tumors, the prognosis for patients with primary hepatocellular carcinoma or metastatic liver cancer remains disheartening. More than 8,000 people die from the disease each year. The majority of patients (approximately 70% to 85%) are diagnosed at an advanced stage or have tumors that are unresectable. In contrast, patients with smaller tumors have a much better chance of achieving a cure. Numerous studies have reported that patients who undergo hepatic lobectomy have a 5-year disease-free survival rate exceeding 50%. For tumors that are not surgically resectable, local ablation techniques such as Radiofrequency Ablation (RFA) have emerged as potentially curative alternatives. However, RFA has significant drawbacks: its percutaneous invasiveness can sometimes lead to bleeding or tumor seeding along the needle tract, and it may be less effective near blood vessels due to the heat-sink effect. Therefore, its application is currently limited to small liver tumors. Histotripsy is a tumor ablation technique developed in recent years that allows for non-invasive treatment of solid tumors using High-Intensity Focused Ultrasound (HIFU). This method works by physically focusing ultrasound energy at a single point within biological tissue, creating a focal zone of high-power, low-frequency ultrasound that induces mechanical fragmentation (histotripsy) and cavitation effects, dissolving the tissue into fragments and destroying tumor cells. Under real-time ultrasound imaging guidance, various scanning treatment protocols are used to move the focal point throughout the treatment zone, effectively ablating the tumor tissue. This clinical trial utilizes the Edison System, developed by HistoSonics Inc. (USA). The first multicenter Phase I human trial of this technology was conducted in 2018, lasting eight weeks and treating 11 patients with advanced, unresectable multifocal liver tumors. All targeted tumors were successfully ablated with no device-related adverse events. This research project aims to evaluate the clinical feasibility and advantages of this system in malignant liver tumor patients who are ineligible for surgical resection but are still candidates for local tumor ablation. To investigators plan to perform ablation under general anesthesia on 20 participants with liver tumors located within 1 cm of the inferior vena cava, hepatic veins, or bilateral portal vein trunks. Post-procedural complications will be monitored, and follow-up over 12 months will assess complete tumor ablation and intrahepatic recurrence to verify the system's clinical viability and potential benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment liver tumors | Experimental | Device: Histotripsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Ages Eligible for Study: 18 Years and older
- Diagnosed with a malignant liver tumor at National Taiwan University Hospital. The diagnosis of liver cancer was based on the international diagnostic criteria of the AASLD, while the diagnosis of other primary malignant liver tumors and metastatic liver tumor was based on pathological diagnostic standards
- Unsuitable for surgical resection. the tumor is located less than 1 cm from critical vascular structures, including the inferior vena cava, hepatic veins, and both main branches of the portal vein.
- Have at least one, but less than or equal to 3 tumors, At least one of them met the third criterion
- Each tumor must be ≤ 5 cm in diameter,
Key exclusion criteria (12 listed)
- Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
- Received treatment with an investigational agent/ procedure within 30 days prior to Histotripsy treatment
- Acute infection or inflammation, acute and severe dysfunction of heart, liver and kidney.
- Known history of HIV infection
- Tumor not clearly visualized on ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HistotripsyHistotripsy is a tumor ablation technique developed in recent years that allows for non-invasive treatment of solid tumors using High-Intensity Focused Ultrasound (HIFU). This method works by physically focusing ultrasound energy at a single point within biological tissue, creating a focal zone of high-power, low-frequency ultrasound that induces mechanical fragmentation (histotripsy) and cavitation effects, dissolving the tissue into fragments and destroying tumor cells. Under real-time ultrasound imaging guidance, various scanning treatment protocols are used to move the focal point throughout the treatment zone, effectively ablating the tumor tissue. The destroyed tumor tissue is gradually absorbed by the body. Since this technique does not require needle puncture, electrode insertion, radiation, or thermal effects, it is minimally invasive and holds the potential to overcome the limitations of existing ablation technologies. | Device | treatment liver tumors |
Primary outcome
Comparison of SF-36 and VAS with preoperative baseline within six months
Time frame: six months
The main goals are to confirm if the quality of life of subjects improves after treatment with a focused ultrasound system and to assess the safety of the treatment. The acceptable safety range, according to CTCAE Version 5.0 criteria, should be Grade 3 or below.
1 secondary outcome
Comparison of Tumor Volume Before and After Treatment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Histotripsy in people with Liver Tumors, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai-Wen Huang, MD, MS, PhD (886-2-23123456 ext. 266144, skywing@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of SF-36 and VAS with preoperative baseline within six months (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.