Malignant Liver Tumors Clinical Trial
Official title:
Evaluation of Tumor Ablation Effects by Irreversible Electroporation for Patients With Malignant Liver Tumors
Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers
is one the most common malignancies in the world. Over 10000 new cases per year are
diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains
dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70%to
85%) of patients present with advanced or unresectable disease. In contrast, small liver
cancers can be cured with an appreciable frequency. Five-year disease-free survival
exceeding 50% has been reported for surgical resection, and for the inoperable patients who
do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is
recommended as an alternative curative therapy. However, the main drawback of RFA is its
limitation to tumor size and location. The tumors larger than 5 cm in diameter or located
adjacent to vessels, could not be ablated completely.
Irreversible electroporation (IRE), developed and manufactured by AngioDynamics US Ltd, can
ablate tumor by fenestrating the cancer cell membrane by electric pulse. The anti-tumor
effect does not result from thermotherapy, so is also not diminished by adjacent vessels.
Several pre-clinical studies have already demonstrated IRE is a safe and effective treatment
for live cancers. The system has received CE mark approval in 2008 and FDA approval in 2010.
However, there is no experience in using IRE fro tumor ablation in Taiwan. In this study,
the investigators will perform intraoperative IRE for the patients with liver cancers who
are scheduled to receive hepatectomy in our hospital, and the investigators will evaluate
the ablate effect of tumors on specimens, and the effect of adjacent vessels. The
investigators will appraisal the clinical feasibility and advantage of the system by this
study.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00869843 -
Study of Saline Linked Monopolar Surface Radiofrequency (RF) Ablation of Hepatic Tumors
|
Phase 1 |