Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of the combined therapy using irreversible electroporation（IRE）and nature killer(NK) cells for advanced pancreatic cancer.

Detailed Description
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By enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using irreversible electroporation（IRE）and nature killer（NK） cells for advanced pancreatic cancer. The efficacy will be evaluated according to relief degree,progress free survival(PFS) and overall survival(OS). The safety will be evaluated by statistics of adverse reaction

Official Title
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Study of the Combined Therapy of Irreversible Electroporation（IRE） and Nature Killer (NK) Cells for Advanced Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Biological: NK cells
* Procedure: irreversible electroporation (IRE )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:18-80 Diagnosis：advanced and active pancreatic cancer The tumour is measurable Eastern Cooperative Oncology Group(ECOG) score：0 2；3 but has no relationship with tumour Vital organ function is normal: total bilirubin(TB) <68μmol/L aspartate aminotransferase(AST)<90 IU/L Cre<353μmol/L white blood cell count(WBC)<9×10^9/L,when WBC is close to or even greater than 9×10^9/L，the recommended dose should be halved platelet count(PLT)>80×10^9/L Red blood cell specific volume(HCT)>0.20 Non severe viral or bacterial infection Non pregnant and lactating patients Non allergic reactions to biological products Informed and consent Exclusion Criteria: Patients with cardiac pacemaker Patients with severe cardiac and pulmonary dysfunction Patients that the researchers do not think fit into the group,including patients failed in compliance assessment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: irreversible electroporation (IRE)<br>Advanced pancreatic cancer patients received only irreversible electroporation (IRE) without immunotherapy | Procedure: irreversible electroporation (IRE )<br>* The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE )<br>|
| Experimental: IRE & NK cells<br>Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells | Biological: NK cells<br>* The pancreatic cancer patients will receive nature killer(NK) cells infusions,qd<br>Procedure: irreversible electroporation (IRE )<br>* The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE )<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief degree | It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST） | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival（PFS） |  | 1 year | 
| Overall survival（OS） |  | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced pancreatic cancer, nature killer cell, irreversible electroporation