Immune Response After Pancreatic Cancer Treatment (IRE Immuno)

Insel Gruppe AG, University Hospital Bern

Status

Terminated

Conditions

Pancreatic Cancer

Treatments

Procedure: irreversible electroporation (IRE)

Study type

Observational

Funder types

Other

Identifiers

NCT03069599

2016-02037

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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