Immune Response After Pancreatic Cancer Treatment

NCT03069599 | Terminated

• 1 other identifier: 2016-02037
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Immunological outcome

  flowcytometry

  42 days

• Immunological outcome

  Flowcytometry

  6 months

• Immunological outcome

  Flowcytometry

  9 months

• Immunological outcome

  ELISA

  42 days

• Immunological outcome

  ELISA

  6 months

• Immunological outcome

  ELISA

  9 months

Secondary Outcomes (16)

• Number of local tumor recurrences

  42 days

• Number of local tumor recurrences

  3 months

• Number of local tumor recurrences

  6 months

• Number of local tumor recurrences

  9 months

• Number of distant tumor recurrences

  42 days

Study Arms (3)

10 IRE locally advanced

patients undergoing in situ IRE for locally advanced pancreatic

Procedure: irreversible electroporation (IRE)

10 IRE borderline resection

patients undergoing margin accentuation IRE for borderline resectable disease

Procedure: irreversible electroporation (IRE)

10 resection only

patients undergoing surgical resection only

Interventions

irreversible electroporation (IRE) 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; 10 IRE locally advanced

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing an established procedure for pancreatic cancer. The assignment into either group will be independent of this research proposal and rely completely on clinical judgment. Main outcomes will be changes in immunological short-term and long-term outcomes.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselhospital

Bern, Switzerland

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Mathias Worni, MD

  Inselspital Berne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: March 3, 2017
• Study Start: February 15, 2017
• Primary Completion: February 25, 2020
• Study Completion: February 25, 2020
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

CH (1)