Irreversible Electroporation(IRE) For Unresectable Hilus Pulmonis Neoplasms

Not Applicable

Completed

• Conditions: Hilus Pulmonary Neoplasms
• Interventions: Procedure: Irreversible electroporation (IRE); Device: NanoKnife

• Registration Number: NCT02430597
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for Hilus Pumonis Neoplasms.

Detailed Description

By enrolling patients with unresectable Head and Hilus Pulmonis 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 Hilus Pulmonis Neoplasms.

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2015-04-26
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-04-30
• Status Verified: 2019-04
• Primary Completion: 2020-12-01
• Study Completion: 2021-03-01
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Hilus Pumonis 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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IRE Group	Irreversible electroporation (IRE)	irreversible electroporation for Unresectable Hilus Pulmonis Neoplasms
IRE Group	NanoKnife	irreversible electroporation for Unresectable Hilus Pulmonis Neoplasms

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse events	6 month

Secondary Outcome Measures

Name	Time	Method
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
Overall survival (OS)	36 months	Patients will be followed for 36 months after IRE for OS analyzed.
Progress free disease (PFS)	12 months

Trial Locations

Locations (1)

Biological treatment center in Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China