Liver CancerNCT07207343
Symptomatic Abdominal Tumors Are Unsuitable for Surgical Resection, High-intensity Focused Ultrasound (HIFU) Treatment Will be Applied to the Tumors. Postoperatively, Continuous Evaluation and Analysis of the Ablation Effect Will be Performed Using CT or MRI Imaging.
A study testing Haifu Focused Ultrasound tumor therapeutic System in people with Liver Cancer and HIFU, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Solid tumors may cause symptoms such as pain due to compression or space-occupying effects. For patients unsuitable for surgical resection, the primary clinical recommendation for malignant tumors is chemotherapy or local radiotherapy to delay tumor progression, improve quality of life, and extend survival. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Cancer, HIFU
- What is being tested?
- Haifu Focused Ultrasound tumor therapeutic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2023to 31 Dec 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 20 years.
- Ability to understand and comply with the routine care requirements of this trial and provide signed informed consent.
- Patients with intra-abdominal tumors measuring 3-10 cm in diameter, such as hepatobiliary and pancreatic cancers, or benign/malignant retroperitoneal tumors, who present with tumor-related symptoms or discomfort.
- Patients deemed unsuitable for surgical resection due to distant metastasis, vascular or vital organ invasion, or the high risk of impaired organ function if resection were performed.
- Good general condition with an ECOG (Eastern Cooperative Oncology Group) performance status of 0-1, and an ASA (American Society of Anesthesiology) score < 3.
- No severe hepatic or renal dysfunction (Child-Pugh class A/B); total bilirubin ≤ 5 mg/dL; ALT and AST ≤ 5 × upper limit of normal; serum creatinine ≤ 2 × upper limit of normal.
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- Normal coagulation function: PT-INR ≤ 2.0, platelet count ≥ 100,000.
- Estimated survival of more than 3 months.
- Maximum tumor depth from skin surface ≤ 11 cm.
Who cannot join
- Tumors that cannot be clearly localized under ultrasound examination.
- No safe acoustic pathway for ultrasound to reach the tumor site upon imaging evaluation, such as when the pathway includes skin scars, bowel gas, calcified tumors, or bones that interfere with ultrasound transmission.
- Pregnant women.
- Participation in any other tumor-related clinical trial within 30 days prior to treatment.
- Radiotherapy to the focused ultrasound treatment area within 30 days before or after treatment.
- Presence of arterial calcification within the treatment area.
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- Requirement for systemic pharmacological treatment within two weeks before or after the procedure.
- Deemed unsuitable for treatment by the principal investigator.
- Presence of surgically related metallic implants in the body.
- Inability to undergo CT/MRI examinations.
- Other contraindications related to the investigational device:
- Poor tolerance to anesthetic agents
- Target tumor located less than 1 cm from the skin surface
- Severe dysfunction of vital organs (heart, liver, kidney, brain, or lung)
- Severe systemic disorders, extreme fatigue, or significant ascites
- Severe diabetes mellitus
- Presence of skin ulceration or impending ulceration
- Target lesion involving major vessels or portal vein thrombosis, or tumors invading vessel walls or causing significant vascular compression
- Tumor invasion into the gastrointestinal or respiratory tract
- Tumor with active infection, unless the infection has been controlled
- Patients with severe collagenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Safety and Efficacy of Ultrasound-guided HIFU for the Symptom Relief of Inoperable Abdominal Tumors.
Solid tumors may cause symptoms such as pain due to compression or space-occupying effects. For patients unsuitable for surgical resection, the primary clinical recommendation for malignant tumors is chemotherapy or local radiotherapy to delay tumor progression, improve quality of life, and extend survival. For benign tumors, however, there are currently no effective alternative recommendations. For unresectable tumors, local ablation therapies such as radiofrequency ablation (RFA) are considered potential curative options. Nonetheless, the major limitations of RFA include its invasive puncture procedure, which may lead to bleeding or needle-track tumor seeding, and its reduced efficacy for tumors located adjacent to blood vessels, thereby restricting its use mainly to small hepatocellular carcinomas.
High-Intensity Focused Ultrasound (HIFU) is an emerging ablation tool developed in recent years that provides non-invasive treatment for solid tumors. Its therapeutic principle involves focusing ultrasound waves onto a single point within biological tissue, where the concentrated energy generates thermal, mechanical, and cavitation effects that destroy tumor cells. Under real-time monitoring with ultrasound imaging systems, the focal point can be moved across the treatment area through various scanning approaches, thereby ablating the targeted tumor tissue. The ablated tissue will gradually be absorbed and replaced by fibrosis within the body. Since HIFU does not require needle puncture into the body, it is considered non-invasive.
This clinical trial will employ the Haifu Focused Ultrasound Tumor Therapeutic System, which was approved and registered by the Taiwan Ministry of Health and Welfare in 2012 for the ablation of uterine fibroids. The proposed study targets patients with intra-abdominal benign or malignant tumors who are unsuitable for surgical resection but present with tumor-related symptoms. Tumors will be treated with HIFU, postoperative complications will be monitored, treatment response will be evaluated one month after therapy, and patient survival will be followed up to verify the clinical feasibility and safety of this system.
- Conditions
- Liver Cancer, HIFU
- Being tested
- Haifu Focused Ultrasound tumor therapeutic System
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haifu Focused Ultrasound tumor therapeutic SystemDevice
Haifu Focused Ultrasound tumor therapeutic System 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 |
|---|---|---|
| symptomatic abdominal tumors who are unsuitable for surgical resection | Experimental | Not described Receives: Device: Haifu Focused Ultrasound tumor therapeutic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. VAS score measures pain intensity using a 10-cm line with "no pain" at 0 point and "worst possible pain" at 10 points.
Measured: six months
SF-36 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. SF-36 score range from 0 to 100, with higher scores indicating better health
Measured: six months
Secondary outcomes (1)
Comparison of Tumor Volume Before and After Treatment
Comparison of tumor volume changes before and after treatment with the focused ultrasound system using CT/MRI imaging, based on RECIST criteria.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies 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
- 38 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
- NCT07207343
- Sponsor's protocol ID
- 202309073DIPB
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety and Efficacy of Ultrasound-guided HIFU for the Symptom Relief of Inoperable Abdominal Tumors.
- ClinicalTrials.gov ID
- NCT07207343
- Acronym / sponsor ID
- 202309073DIPB
- Conditions
- Liver Cancer, HIFU
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Oct 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.
Solid tumors may cause symptoms such as pain due to compression or space-occupying effects. For patients unsuitable for surgical resection, the primary clinical recommendation for malignant tumors is chemotherapy or local radiotherapy to delay tumor progression, improve quality of life, and extend survival. For benign tumors, however, there are currently no effective alternative recommendations. For unresectable tumors, local ablation therapies such as radiofrequency ablation (RFA) are considered potential curative options. Nonetheless, the major limitations of RFA include its invasive puncture procedure, which may lead to bleeding or needle-track tumor seeding, and its reduced efficacy for tumors located adjacent to blood vessels, thereby restricting its use mainly to small hepatocellular carcinomas.
High-Intensity Focused Ultrasound (HIFU) is an emerging ablation tool developed in recent years that provides non-invasive treatment for solid tumors. Its therapeutic principle involves focusing ultrasound waves onto a single point within biological tissue, where the concentrated energy generates thermal, mechanical, and cavitation effects that destroy tumor cells. Under real-time monitoring with ultrasound imaging systems, the focal point can be moved across the treatment area through various scanning approaches, thereby ablating the targeted tumor tissue. The ablated tissue will gradually be absorbed and replaced by fibrosis within the body. Since HIFU does not require needle puncture into the body, it is considered non-invasive.
This clinical trial will employ the Haifu Focused Ultrasound Tumor Therapeutic System, which was approved and registered by the Taiwan Ministry of Health and Welfare in 2012 for the ablation of uterine fibroids. The proposed study targets patients with intra-abdominal benign or malignant tumors who are unsuitable for surgical resection but present with tumor-related symptoms. Tumors will be treated with HIFU, postoperative complications will be monitored, treatment response will be evaluated one month after therapy, and patient survival will be followed up to verify the clinical feasibility and safety of this system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| symptomatic abdominal tumors who are unsuitable for surgical resection | Experimental | Device: Haifu Focused Ultrasound tumor therapeutic System |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 20 years.
- Ability to understand and comply with the routine care requirements of this trial and provide signed informed consent.
- Patients with intra-abdominal tumors measuring 3-10 cm in diameter, such as hepatobiliary and pancreatic cancers, or benign/malignant retroperitoneal tumors, who present with tumor-related symptoms or discomfort.
- Patients deemed unsuitable for surgical resection due to distant metastasis, vascular or vital organ invasion, or the high risk of impaired organ function if resection were performed.
- Good general condition with an ECOG (Eastern Cooperative Oncology Group) performance status of 0-1, and an ASA (American Society of Anesthesiology) score < 3.
Key exclusion criteria (21 listed)
- Tumors that cannot be clearly localized under ultrasound examination.
- No safe acoustic pathway for ultrasound to reach the tumor site upon imaging evaluation, such as when the pathway includes skin scars, bowel gas, calcified tumors, or bones that interfere with ultrasound transmission.
- Pregnant women.
- Participation in any other tumor-related clinical trial within 30 days prior to treatment.
- Radiotherapy to the focused ultrasound treatment area within 30 days before or after treatment.
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 |
|---|---|---|
| Haifu Focused Ultrasound tumor therapeutic SystemHaifu Focused Ultrasound tumor therapeutic System 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 | symptomatic abdominal tumors who are unsuitable for surgical resection |
Primary outcome
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. VAS score measures pain intensity using a 10-cm line with "no pain" at 0 point and "worst possible pain" at 10 points.
SF-36 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. SF-36 score range from 0 to 100, with higher scores indicating better health
1 secondary outcome
Comparison of Tumor Volume Before and After Treatment
Time frame: six 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 3 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haifu Focused Ultrasound tumor therapeutic System in people with Liver Cancer and HIFU, run by National Taiwan University Hospital at 1 site in Taiwan.
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 9 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS with preoperative baseline within six months (time frame: six months). The study lists 2 primary outcomes in all. 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 3 Oct 2025.