The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Head and Neck Neoplasms.
By enrolling patients with unresectable Head and Neck Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Head and Neck Neoplasms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
15
Irreversible Electroportion For Unresectable Head and Neck Neoplasms guide with ultrasound or/and CT.
Biological treatment center in Fuda cancer hospital
Guangzhou, Guangdong, China
Number of participants with Adverse events
Time frame: 6 month
Percentage of lesions that show no sign of recurrence 12 months after IRE
Time frame: 12 months
Voltage (A minimum and maximum range of voltage for safe and effective IRE)
A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.
Time frame: 3 months
Progress free disease (PFS)
Time frame: 12 months
Overall survival (OS)
Patients will be followed for 36 months after IRE for OS analyzed.
Time frame: 36 months
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