Liver Cancer
Conditions
Keywords
irreversible electroporation, Portal venous tumor emboli
Brief summary
The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Portal venous tumor emboli.
Detailed description
By enrolling patients with unresectable Portal venous tumor emboli adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous or intraoperative IRE for unresectable Portal venous tumor emboli.
Interventions
PROCEDUREIrreversible electroporation (IRE)
Irreversible Electroportion For Unresectable Portal venous tumor emboli guide with ultrasound or/and CT.
Sponsors
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Liver cancer diagnosed by positive biopsy or non-invasive criteria, * Liver cancer with Portal venous tumor emboli, * Not suitable for surgical resection or transplantation, * Child-Pugh class A,B * Eastern Cooperative Oncology Group (ECOG) score of 0-1, * A prothrombin time ratio \> 50%, * Platelet count \> 80x10\^9/L, * Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure, * Able to comprehend and willing to sign the written informed consent form (ICF), * Have a life expectancy of at least 3 months.
Exclusion criteria
* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * Any active implanted device (eg Pacemaker), * Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System, * Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (adverse effects) | 6 month | adverse effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy (percentage of lesions that show no sign of recurrence 12 months after IRE) | 12 months | The primary objective of this project is to evaluate the efficacy (percentage of lesions that show no sign of recurrence 12 months after IRE） |
| Voltage (A minimum and maximum range of voltage for safe and effective IRE) | 3 months | A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice. |
| Progress free disease (PFS) | 12 months | Patients will be followed for 12 months after IRE for PFS assessing. |
| Overall survival (OS) | 36 months | Patients will be followed for 36 months after IRE for OS analyzed. |
Countries
China
Outcome results
None listed