New electric pulse therapy tackles inoperable liver tumors near vital vessels
NCT ID NCT07214363
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a treatment called irreversible electroporation (IRE) for people with liver cancer who cannot have surgery because their tumors are too close to major blood vessels. IRE uses short, strong electrical pulses to destroy cancer cells without harming nearby blood vessels. The study will enroll 20 participants and follow them for 4 months to see if the tumors are completely destroyed and to check for side effects.
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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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Dec 2026
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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20 years and older
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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, * 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. Exclusion Criteria: -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, * 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
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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.
Contacts and locations
Locations
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National Taiwan University Hospital
Taipei, 100, Taiwan
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Other studies related to the condition(s) this trial covers.
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