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Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02718859
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Shenzhen Hank Bioengineering Institute
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: NK cells Procedure: irreversible electroporation (IRE ) Phase 1 Phase 2

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Combined Therapy of Irreversible Electroporation(IRE) and Nature Killer (NK) Cells for Advanced Pancreatic Cancer
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: irreversible electroporation (IRE)
Advanced pancreatic cancer patients received only irreversible electroporation (IRE) without immunotherapy
Procedure: irreversible electroporation (IRE )
The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE )

Experimental: IRE & NK cells
Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells
Biological: NK cells
The pancreatic cancer patients will receive nature killer(NK) cells infusions,qd

Procedure: irreversible electroporation (IRE )
The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE )




Primary Outcome Measures :
  1. Relief degree [ Time Frame: 1 year ]
    It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)


Secondary Outcome Measures :
  1. Progress free survival(PFS) [ Time Frame: 1 year ]
  2. Overall survival(OS) [ Time Frame: 3 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age:18-80
  2. Diagnosis:advanced and active pancreatic cancer
  3. The tumour is measurable
  4. Eastern Cooperative Oncology Group(ECOG) score:0~2;3 but has no relationship with tumour
  5. 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

  6. Non pregnant and lactating patients
  7. Non allergic reactions to biological products
  8. Informed and consent

Exclusion Criteria:

  1. Patients with cardiac pacemaker
  2. Patients with severe cardiac and pulmonary dysfunction
  3. Patients that the researchers do not think fit into the group,including patients failed in compliance assessment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718859


Locations
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China, Guangdong
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Shenzhen Hank Bioengineering Institute
Investigators
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Study Chair: Lizhi Niu, PhD Fuda Cancer Hospital

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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02718859     History of Changes
Other Study ID Numbers: NK-pancre
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: March 2019
Keywords provided by Fuda Cancer Hospital, Guangzhou:
advanced pancreatic cancer
nature killer cell
irreversible electroporation
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases