Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 9, 2016
First Posted Date  ICMJE March 24, 2016
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE March 1, 2016
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2016)
Relief degree [ Time Frame: 1 year ]
It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02718859 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2016)
  • Progress free survival(PFS) [ Time Frame: 1 year ]
  • Overall survival(OS) [ Time Frame: 3 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer
Official Title  ICMJE Study of the Combined Therapy of Irreversible Electroporation(IRE) and Nature Killer (NK) Cells for Advanced Pancreatic Cancer
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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • 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 )
Study Arms  ICMJE
  • Active Comparator: irreversible electroporation (IRE)
    Advanced pancreatic cancer patients received only irreversible electroporation (IRE) without immunotherapy
    Intervention: Procedure: irreversible electroporation (IRE )
  • Experimental: IRE & NK cells
    Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells
    Interventions:
    • Biological: NK cells
    • Procedure: irreversible electroporation (IRE )
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2019
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02718859
Other Study ID Numbers  ICMJE NK-pancre
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fuda Cancer Hospital, Guangzhou
Study Sponsor  ICMJE Fuda Cancer Hospital, Guangzhou
Collaborators  ICMJE Shenzhen Hank Bioengineering Institute
Investigators  ICMJE
Study Chair: Lizhi Niu, PhD Fuda Cancer Hospital
PRS Account Fuda Cancer Hospital, Guangzhou
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP