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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | irreversible electroporation with voltage in level A for Unresectable Head and Neck Neoplasms |
|
| Group B | Experimental | irreversible electroporation with voltage in level B for Unresectable Head and Neck Neoplasms |
|
| Group C | Experimental | irreversible electroporation with voltage in level C for Unresectable Head and Neck Neoplasms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irreversible electroporation (IRE) | Procedure | Irreversible Electroportion For Unresectable Head and Neck Neoplasms guide with ultrasound or/and CT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse events | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lizhi Niu, PHD | Fuda Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biological treatment center in Fuda cancer hospital | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D018274 | Electroporation |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |
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|
| NanoKnife | Device |
|
| 3 months |
| Progress free disease (PFS) | 12 months |
| Overall survival (OS) | Patients will be followed for 36 months after IRE for OS analyzed. | 36 months |