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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