Irreversible Electroporation(IRE) For Lung Neoplasms Accompanied by Respiratory Function Insufficiency

Not Applicable

Completed

Conditions: Lung Neoplasms Accompanied by Respiratory Function Insufficiency

Interventions: Procedure: Irreversible electroporation (IRE)
Device: NanoKnife

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for Lung Neoplasms accompanied by Respiratory Function Insufficiency.

Detailed Description: By enrolling patients with Lung Neoplasms accompanied by Respiratory Function Insufficiency 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 Lung Neoplasms accompanied by Respiratory Function Insufficiency.

Recruitment & Eligibility

Inclusion Criteria

Lung Neoplasms Accompanied by Respiratory Function Insufficiency 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.

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.

Arm && Interventions

Group	Intervention	Description
IRE Group	Irreversible electroporation (IRE)	irreversible electroporation for Lung Neoplasms accompanied by Respiratory Function Insufficiency
IRE Group	NanoKnife	irreversible electroporation for Lung Neoplasms accompanied by Respiratory Function Insufficiency

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse events	6 month

Secondary Outcome Measures

Name	Time	Method
Progress free disease (PFS)	12 months	A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.
Overall survival (OS)	36 months	Patients will be followed for 36 months after IRE for OS analyzed.
Percentage of lesions that show no sign of recurrence 12 months after IRE	12 months
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.

Locations (1): Biological treatment center in Fuda cancer hospital
🇨🇳
Guangzhou, Guangdong, China