Immune Response After Pancreatic Cancer Treatment

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Procedure: irreversible electroporation (IRE)

• Registration Number: NCT03069599
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-20
• Study Start: 2017-02-15
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-03
• Status Verified: 2020-02
• Primary Completion: 2020-02-25
• Study Completion: 2020-02-25
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
10 IRE borderline resection	irreversible electroporation (IRE)	patients undergoing margin accentuation IRE for borderline resectable disease
10 IRE locally advanced	irreversible electroporation (IRE)	patients undergoing in situ IRE for locally advanced pancreatic

Primary Outcome Measures

Name	Time	Method
Immunological outcome	9 months	ELISA

Secondary Outcome Measures

Name	Time	Method
Number of local tumor recurrences	9 months	measured via CT
Overall survival	9 months	survival of patient
Number of distant tumor recurrences	9 months	measured via CT
Cancer specific survival	9 months	survival of patient

Trial Locations

Locations (1)

Inselhospital; 🇨🇭 Bern, Switzerland