Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer
NCT ID: NCT02718859
Last Updated: 2019-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2016-03-01
2019-03-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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irreversible electroporation (IRE)
Advanced pancreatic cancer patients received only irreversible electroporation (IRE) without immunotherapy
irreversible electroporation (IRE )
The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE )
IRE & NK cells
Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells
NK cells
The pancreatic cancer patients will receive nature killer(NK) cells infusions,qd
irreversible electroporation (IRE )
The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE )
Interventions
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NK cells
The pancreatic cancer patients will receive nature killer(NK) cells infusions,qd
irreversible electroporation (IRE )
The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE )
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Shenzhen Hank Bioengineering Institute
OTHER
Fuda Cancer Hospital, Guangzhou
OTHER
Responsible Party
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Principal Investigators
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Lizhi Niu, PhD
Role: STUDY_CHAIR
Fuda Cancer Hospital
Locations
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Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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NK-pancre
Identifier Type: -
Identifier Source: org_study_id
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