Immune Response After Pancreatic Cancer Treatment

NCT ID: NCT03069599

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2020-02-25

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.

Conditions

Pancreatic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

10 IRE locally advanced

patients undergoing in situ IRE for locally advanced pancreatic

irreversible electroporation (IRE)

Intervention Type: PROCEDURE

Irreversible electroporation is an emerging, mainly non-thermal ablative modality. It circumvents some downsides of thermal ablation and has the potential for broad application among patients with pancreatic cancer.

10 IRE borderline resection

patients undergoing margin accentuation IRE for borderline resectable disease

irreversible electroporation (IRE)

Intervention Type: PROCEDURE

Irreversible electroporation is an emerging, mainly non-thermal ablative modality. It circumvents some downsides of thermal ablation and has the potential for broad application among patients with pancreatic cancer.

10 resection only

patients undergoing surgical resection only

No interventions assigned to this group

Interventions

irreversible electroporation (IRE)

Irreversible electroporation is an emerging, mainly non-thermal ablative modality. It circumvents some downsides of thermal ablation and has the potential for broad application among patients with pancreatic cancer.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathias Worni, MD

Role: PRINCIPAL_INVESTIGATOR

Inselspital Berne

Locations

Inselhospital

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

2016-02037

Identifier Type: -

Identifier Source: org_study_id