Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer
Overview
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.
Full Title of Study: “Study of the Combined Therapy of Irreversible Electroporation(IRE) and Nature Killer (NK) Cells for Advanced Pancreatic Cancer”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 1, 2017
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
Interventions
- 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 )
Arms, Groups and Cohorts
- Active Comparator: irreversible electroporation (IRE)
- Advanced pancreatic cancer patients received only irreversible electroporation (IRE) without immunotherapy
- Experimental: IRE & NK cells
- Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells
Clinical Trial Outcome Measures
Primary Measures
- Relief degree
- Time Frame: 1 year
- It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)
Secondary Measures
- Progress free survival(PFS)
- Time Frame: 1 year
- Overall survival(OS)
- Time Frame: 3 year
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Fuda Cancer Hospital, Guangzhou
- Collaborator
- Shenzhen Hank Bioengineering Institute
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Lizhi Niu, PhD, Study Chair, Fuda Cancer Hospital
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