Immune Response After Pancreatic Cancer Treatment

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Brief Title

Immune Response After Pancreatic Cancer Treatment

Official Title

Differential Immunologic Signature After Pancreatic Cancer Treatment: Does Irreversible Electroporation Lead to a Prolonged and Potent T-cell Mediated Immune Response Compared to Surgical Resection?

Brief Summary

      The aim of this project is to describe the differential immunologic responses of patients who
      undergo in situ IRE, margin accentuation IRE with surgical resection of the primary tumor,
      and surgical resection of the primary tumor only. The primary hypothesis is that IRE induces
      a long and sustained activation of the cell-mediated immune system, which is distinct from
      the immune response after surgical resection only. The primary endpoint of this study is the
      comparison of the CD4+/CD8+ ratio as an indicator of antitumor immunity both longitudinally
      within a group after the intervention and over time between the three groups. CD4+/CD8+ ratio
      will be measured preoperatively and at postoperative days 1, 7, 42, and 180. As a secondary
      outcome, additional measurements will be taken to more specifically characterize the immune
      response based on peripheral blood samples. Flow cytometry will be used to quantify cell
      subsets, and ELISA will be used to measure cytokine levels , at the same time-points as for
      the primary outcome. Each group of patients as described above will consist of 10 consecutive
      pancreatic cancer patients. Patients aged 18 or older with resectable, borderline resectable,
      or locally advanced pancreatic cancer will be included. Patients with locally advanced
      disease will undergo 3 months of preoperative chemotherapy with monitoring to exclude
      metastatic disease. Main exclusion criteria are cardiac conduction abnormalities and signs of
      distant metastasis.
    



Study Type

Observational


Primary Outcome

Immunological outcome

Secondary Outcome

 Number of local tumor recurrences

Condition

Pancreatic Cancer

Intervention

irreversible electroporation (IRE)

Study Arms / Comparison Groups

 10 IRE locally advanced
Description:  patients undergoing in situ IRE for locally advanced pancreatic

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

30

Start Date

February 15, 2017

Completion Date

January 2024

Primary Completion Date

January 2024

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Able to undergo general anesthesia (ASA ≤ 4)

          -  Performance status ECOG <=2 (Eastern Cooperative Oncology Group)

          -  Life expectancy of at least 6 months

          -  Resectable, borderline resectable, or locally advanced pancreatic cancer

          -  Patients who have locally advanced disease have to show no tumor progression after 3
             month of neo-adjuvant chemotherapy+/-XRT before undergoing in situ IRE

        Exclusion Criteria:

          -  Cardiac AV conduction abnormalities, ventricular fibrillation

          -  History of epilepsy

          -  Recent history of myocardial infarction (2 months)

          -  Evidence of distant metastasis (e.g. liver, lung, peritoneum)

          -  Informed consent cannot be given by the patient

          -  Known hypersensitivity to the IRE electrodes (stainless steel 304L)

          -  Women of childbearing potential who are pregnant, breast feeding, or not taking an
             adequate method of contraception at the time of procedure
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mathias Worni, MD, , 

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT03069599

Organization ID

2016-02037


Responsible Party

Sponsor

Study Sponsor

University Hospital Inselspital, Berne


Study Sponsor

Mathias Worni, MD, Principal Investigator, Inselspital Berne


Verification Date

September 2019