Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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In this study, effects of γδT cells on human Pancreatic Cancer in combination with tumor reducing surgery, for example IRE going to be investigated.

Detailed Description
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Pancreatic tumor will be removed using tumor reducing surgery such as IRE. PBMC of the healthy donor will be separated from peripheral blood. After making them potential cancer killer γδ T Cell, they will be infused to the patients as an immunotherapy treatment.

Official Title
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Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Procedure: IRE surgery
* Biological: IRE plus γδ T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: >18 years participants older than 18 years with either LAPC according to the American Joint Committee on Cancer (AJCC) criteria or isolated local recurrence with a maximum tumor diameter of 5 cm were considered eligible after pathologic confirmation will receive IRE, gd Tcells life expectancy: more than 3 months ability to understand the study protocol and a willingness to sign a written informed consent document adequate liver and renal function were required intolerant or refused to chemotherapy or to chemotherapy Exclusion Criteria: patients with other kinds of cancer history of coagulation disorders or anemia heart disease and diabetes history of epilepsy, severe coronary disease, a history of level 3 hypertension，myelosuppression, autoimmune disease a performance status score of >2

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: Group A<br>In this group, the patients will receive IRE surgery to control the local tumor under CT . | Procedure: IRE surgery<br>* IRE surgery will be used in local tumor<br>|
| Experimental: Group B<br>In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and IRE surgery | Biological: IRE plus γδ T cells<br>* Combination IRE surgery and γδ T cell will be used in Pancreatic Cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | PFS was defined as the interval between treatment initiation and local relapse | 2 years | 
| OS | OS was calculated as the interval from treatment initiation to death. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor size | The tumor responses of the enrolled patients were assessed by CT in accordance with RECIST v1.1.Institute Common Terminology Criteria for Adverse Events (v4.0). | 3 months | 
| CTC | The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels. | 3 months | 
| CA 19-9 | The serum concentrations of CA19-9 were evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapy, γδ T Cell, Pancreatic Cancer