National Taiwan University Hospital
Taipei, 100, Taiwan
NCT Number: NCT07214363
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.
This study is active but is not currently recruiting participants.
20 year and older
All sexes
Interventional
Not applicable
Taipei, 100, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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)
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.
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
Time frame: 4 months
Time frame: 4 months
National Taiwan University Hospital
Other
Malignant Liver Tumors Who Are Unsuitable for Surgical Resection, Irreversible Electroporation (IRE) Ablation Will be Performed for Tumors Located Adjacent to Blood Vessels.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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