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| Name | Class |
|---|---|
| Shenzhen Hank Bioengineering Institute | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| irreversible electroporation (IRE) | Active Comparator | Advanced pancreatic cancer patients received only irreversible electroporation (IRE) without immunotherapy |
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| IRE & NK cells | Experimental | Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NK cells | Biological | The pancreatic cancer patients will receive nature killer(NK) cells infusions,qd |
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| Measure | Description | Time Frame |
|---|---|---|
| Relief degree | It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival(PFS) | 1 year | |
| Overall survival(OS) | 3 year |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Lizhi Niu, PhD | Fuda Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central laboratory in Fuda cancer hospital | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland 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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| irreversible electroporation (IRE ) | Procedure | The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE ) |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |