Liver CancerNCT07214363
The Safety and Efficacy of Irreversible Electroporation for the Treatment of Perivascular Liver Cancers
A study testing Irreversible Electroporation Ablation Generator in people with Liver Cancer and Ablation Techniques, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Malignant liver tumors are among the most common cancers worldwide, with over 10,000 new cases reported annually in Taiwan. Despite the availability of various treatment options, the prognosis for primary hepatocellular carcinoma and other metastatic liver cancers remains poor, with more than 8,000 deaths each year. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Cancer, Ablation Techniques, Radiology
- What is being tested?
- Irreversible Electroporation Ablation Generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 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
- Malignant liver cancer including hepatocellular carcinoma (HCC), cholangiocarcinoma and metastatic liver cancers, The diagnosis of cholangiocarcinoma or metastatic liver cancers with pathologic proven, and the diagnosis of HCC will be made by pathology / cytology or according to the AASLD (2018) diagnostic criteria. In brief, Nodules larger than 1 cm found on ultrasound screening of a cirrhotic liver should be investigated further with either tri-phase multidetector CT scan or dynamic contrast enhanced MRI. If the appearances are typical of HCC (i.e., hypervascular in the arterial phase with washout in the portal venous or delayed phase), the lesion should be treated as HCC. If the findings are not characteristic or the vascular profile is not typical, a second contrast enhanced study with the other imaging modality should be performed, or the lesion should be biopsied. Biopsies of small lesions should be evaluated by expert pathologists. Tissue that is not clearly HCC should be stained with all the available markers including CD34, CK7, glypican 3, HSP-70, and glutamine synthetase to improve diagnostic accuracy.
- Unsuitable for surgical resection but local ablation is indicated, however, the distance between tumour and inferior vena cava, hepatic veins or bilateral; portal veins is smaller than 1 cm.
- The patient can tolerate endotracheal intubation and general anaesthesia.
- The tumour number is less than or equal to 3,
- Maximal tumor size 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). PT-INR ≦ 2.0. (2). Platelet count ≥ 100 K/Μl (3). Total bilirubin ≦ 3 mg/dL (4). ALT and AST < 5 x upper limit of normal
- Prior Informed Consent Form
- Life expectancy of at least 3 months.
Who cannot join
- -History of cardiac disease: (A)Congestive heart failure >NYHA class 2; (B)Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening); (C)Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers are permitted)
- Immunotherapy or chemotherapy ≤ 6 weeks prior to the procedure;
- Contraindicated to abdominal CT and MRI
- Allergy to muscle relaxant.
- History of epilepsy
- Women who are pregnant or women of child-bearing potential without using an acceptable method of contraception,
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- Patients received treatment with an investigational agent/ procedure within 30 days.
- Patients with hypertension or arrythmia under poor medical control
- Acute infection or inflammation, acute and severe dysfunction of heart, liver and kidney, and the patients with metallic implantation including pacemaker.
- Known history of HIV infection
- Concurrent extrahepatic cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Malignant Liver Tumors Who Are Unsuitable for Surgical Resection, Irreversible Electroporation (IRE) Ablation Will be Performed for Tumors Located Adjacent to Blood Vessels.
Malignant liver tumors are among the most common cancers worldwide, with over 10,000 new cases reported annually in Taiwan. Despite the availability of various treatment options, the prognosis for primary hepatocellular carcinoma and other metastatic liver cancers remains poor, with more than 8,000 deaths each year. The majority of patients (approximately 70%-85%) are diagnosed at an advanced stage or are deemed unresectable. In contrast, patients with small tumors often have a chance of cure. According to numerous studies, patients undergoing hepatic resection achieve a five-year disease-free survival rate exceeding 50%.
For patients with unresectable malignant liver tumors who do not have vascular invasion or extrahepatic metastasis, radiofrequency ablation (RFA) serves as an alternative curative treatment. However, a major limitation of RFA lies in its reduced efficacy when tumors are located near blood vessels, making complete ablation difficult. Irreversible electroporation (IRE) offers a safer ablation modality that is unaffected by vascular proximity. Both preclinical and clinical studies have demonstrated that IRE is a safe and effective treatment for liver tumors. According to reports in the international journal Radiology, complete ablation rates of 77.3%-92% have been achieved in patients with liver cancer treated with IRE, with complication rates of around 19%, most of which were mild.
The irreversible electroporation ablation system (Irreversible Electroporation Ablation Generator) used in this study delivers an ablation field with a voltage of 3,000 volts. It received U.S. Food and Drug Administration (FDA) approval in 2023 but has not yet been introduced in Taiwan. This study will target patients with malignant liver tumors who are unsuitable for surgical resection but are eligible for local ablation therapy, specifically those with tumors located adjacent to the inferior vena cava, hepatic veins, or within 1 cm of the main trunks of both portal veins. A total of 20 patients will undergo ablation treatment under intubation and general anesthesia. Postoperative monitoring will focus on potential complications, and patients will be followed for four months to assess complete tumor ablation and intrahepatic recurrence, in order to verify the clinical feasibility and advantages of this system.
- Conditions
- Liver Cancer, Ablation Techniques, Radiology
- Being tested
- Irreversible Electroporation Ablation Generator
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible Electroporation Ablation GeneratorDevice
The irreversible electroporation ablation system (Irreversible Electroporation Ablation Generator) used in this study delivers an ablation field with a voltage of 3,000 volts. It received U.S. Food and Drug Administration (FDA) approval in 2023 but has not yet been introduced in Taiwan. This study will target participants with malignant liver tumors who are unsuitable for surgical resection but are eligible for local ablation therapy, specifically those with tumors located adjacent to the inferior vena cava, hepatic veins, or within 1 cm of the main trunks of both portal veins. A total of 20 participants will undergo ablation treatment under intubation and general anesthesia. Postoperative monitoring will focus on potential complications, and participants will be followed for four months to assess complete tumor ablation and intrahepatic recurrence, in order to verify the clinical feasibility and advantages of this system.
| Study group | Role | What they receive |
|---|---|---|
| liver tumors are unsuitable for surgical resection | Experimental | Participants with liver cancer, considered for local treatment of liver tumors of size measuring <5 cm and without any signs of extra-hepatic metastasis, will be enrolled to be treated Receives: Device: Irreversible Electroporation Ablation Generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate the efficacy of irreversible electroporation for the treatment of primary or secondary liver cancers in participants who are not suitable candidates for surgical intervention.
The primary measure for this will be the evaluation of tumor response according to the modified RECIST criteria by CT or MR imaging performed
Measured: 1 month
Secondary outcomes (2)
Safety using the CTCAE Version 4.0 criteria
Measured: 4 months
local tumor recurrences
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start1 Oct 2023
- Primary completion1 Oct 2023
- 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
- 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
- NCT07214363
- Sponsor's protocol ID
- 202309001DIPC
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malignant Liver Tumors Who Are Unsuitable for Surgical Resection, Irreversible Electroporation (IRE) Ablation Will be Performed for Tumors Located Adjacent to Blood Vessels.
- ClinicalTrials.gov ID
- NCT07214363
- Acronym / sponsor ID
- 202309001DIPC
- Conditions
- Liver Cancer, Ablation Techniques, Radiology
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 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.
Malignant liver tumors are among the most common cancers worldwide, with over 10,000 new cases reported annually in Taiwan. Despite the availability of various treatment options, the prognosis for primary hepatocellular carcinoma and other metastatic liver cancers remains poor, with more than 8,000 deaths each year. The majority of patients (approximately 70%-85%) are diagnosed at an advanced stage or are deemed unresectable. In contrast, patients with small tumors often have a chance of cure. According to numerous studies, patients undergoing hepatic resection achieve a five-year disease-free survival rate exceeding 50%.
For patients with unresectable malignant liver tumors who do not have vascular invasion or extrahepatic metastasis, radiofrequency ablation (RFA) serves as an alternative curative treatment. However, a major limitation of RFA lies in its reduced efficacy when tumors are located near blood vessels, making complete ablation difficult. Irreversible electroporation (IRE) offers a safer ablation modality that is unaffected by vascular proximity. Both preclinical and clinical studies have demonstrated that IRE is a safe and effective treatment for liver tumors. According to reports in the international journal Radiology, complete ablation rates of 77.3%-92% have been achieved in patients with liver cancer treated with IRE, with complication rates of around 19%, most of which were mild.
The irreversible electroporation ablation system (Irreversible Electroporation Ablation Generator) used in this study delivers an ablation field with a voltage of 3,000 volts. It received U.S. Food and Drug Administration (FDA) approval in 2023 but has not yet been introduced in Taiwan. This study will target patients with malignant liver tumors who are unsuitable for surgical resection but are eligible for local ablation therapy, specifically those with tumors located adjacent to the inferior vena cava, hepatic veins, or within 1 cm of the main trunks of both portal veins. A total of 20 patients will undergo ablation treatment under intubation and general anesthesia. Postoperative monitoring will focus on potential complications, and patients will be followed for four months to assess complete tumor ablation and intrahepatic recurrence, in order to verify the clinical feasibility and advantages 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 |
|---|---|---|
| liver tumors are unsuitable for surgical resection | Experimental | Device: Irreversible Electroporation Ablation GeneratorParticipants with liver cancer, considered for local treatment of liver tumors of size measuring <5 cm and without any signs of extra-hepatic metastasis, will be enrolled to be treated |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Malignant liver cancer including hepatocellular carcinoma (HCC), cholangiocarcinoma and metastatic liver cancers, The diagnosis of cholangiocarcinoma or metastatic liver cancers with pathologic proven, and the diagnosis of HCC will be made by pathology / cytology or according to the AASLD (2018) diagnostic criteria. In brief, Nodules larger than 1 cm found on ultrasound screening of a cirrhotic liver should be investigated further with either tri-phase multidetector CT scan or dynamic contrast enhanced MRI. If the appearances are typical of HCC (i.e., hypervascular in the arterial phase with washout in the portal venous or delayed phase), the lesion should be treated as HCC. If the findings are not characteristic or the vascular profile is not typical, a second contrast enhanced study with the other imaging modality should be performed, or the lesion should be biopsied. Biopsies of small lesions should be evaluated by expert pathologists. Tissue that is not clearly HCC should be stained with all the available markers including CD34, CK7, glypican 3, HSP-70, and glutamine synthetase to improve diagnostic accuracy.
- Unsuitable for surgical resection but local ablation is indicated, however, the distance between tumour and inferior vena cava, hepatic veins or bilateral; portal veins is smaller than 1 cm.
- The patient can tolerate endotracheal intubation and general anaesthesia.
- The tumour number is less than or equal to 3,
- Maximal tumor size must be ≤ 5 cm in diameter,
Key exclusion criteria (11 listed)
- -History of cardiac disease: (A)Congestive heart failure >NYHA class 2; (B)Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening); (C)Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers are permitted)
- Immunotherapy or chemotherapy ≤ 6 weeks prior to the procedure;
- Contraindicated to abdominal CT and MRI
- Allergy to muscle relaxant.
- History of epilepsy
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 |
|---|---|---|
| Irreversible Electroporation Ablation GeneratorThe irreversible electroporation ablation system (Irreversible Electroporation Ablation Generator) used in this study delivers an ablation field with a voltage of 3,000 volts. It received U.S. Food and Drug Administration (FDA) approval in 2023 but has not yet been introduced in Taiwan. This study will target participants with malignant liver tumors who are unsuitable for surgical resection but are eligible for local ablation therapy, specifically those with tumors located adjacent to the inferior vena cava, hepatic veins, or within 1 cm of the main trunks of both portal veins. A total of 20 participants will undergo ablation treatment under intubation and general anesthesia. Postoperative monitoring will focus on potential complications, and participants will be followed for four months to assess complete tumor ablation and intrahepatic recurrence, in order to verify the clinical feasibility and advantages of this system. | Device | liver tumors are unsuitable for surgical resection |
Primary outcome
The primary objective of this study is to evaluate the efficacy of irreversible electroporation for the treatment of primary or secondary liver cancers in participants who are not suitable candidates for surgical intervention.
Time frame: 1 month
The primary measure for this will be the evaluation of tumor response according to the modified RECIST criteria by CT or MR imaging performed
2 secondary outcomes
Safety using the CTCAE Version 4.0 criteria
Time frame: 4 months
local tumor recurrences
Time frame: 4 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 9 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 Irreversible Electroporation Ablation Generator in people with Liver Cancer and Ablation Techniques, 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 11 inclusion and 11 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 9 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?
The primary objective of this study is to evaluate the efficacy of irreversible electroporation for the treatment of primary or secondary liver cancers in participants who are not suitable candidates for surgical intervention. (time frame: 1 month). 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 9 Oct 2025.