Irreversible Electroporation(IRE) For Unresectable Renal Pelvic and Ureteral Neoplasms
The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Renal Pelvic and Ureteral Neoplasms.
|Condition or Disease||Intervention/Treatment||Phase|
By enrolling patients with unresectable Renal Pelvic and Ureteral 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 Renal Pelvic and Ureteral Neoplasms.
Arms and Interventions
|Experimental: IRE Group|
irreversible electroporation for Unresectable Renal Pelvic and Ureteral Neoplasms
Procedure: rreversible electroporation (IRE)
Irreversible Electroportion For Unresectable Renal Pelvic and Ureteral Neoplasms guide with ultrasound or/and CT.
|No Intervention: Control|
The patients without treatment
Primary Outcome Measures
- Number of participants with Adverse events [6 month]
Secondary Outcome Measures
- Percentage of lesions that show no sign of recurrence 12 months after IRE [12 months]
- 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
- Progress free disease (PFS) [12 months]
- Overall survival (OS) [36 months]
Patients will be followed for 36 months after IRE for OS analyzed.
Renal Pelvic and Ureteral Neoplasms diagnosed by positive biopsy or non-invasive criteria,
Not suitable for surgical resection,
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.
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.
Contacts and Locations
|1||Biological treatment center in Fuda cancer hospital||Guangzhou||Guangdong||China||510000|
Sponsors and Collaborators
- Fuda Cancer Hospital, Guangzhou
- Study Chair: Lizhi Niu, PhD, Fuda Cancer Hospital
Study Documents (Full-Text)None provided.
- pelvis ureter Neoplasms-IRE-01