Immune Response After Pancreatic Cancer Treatment

Pancreatic Cancer Clinical Trial

— IRE Immuno  

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?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03069599
• Other study ID #: 2016-02037
• Status: Terminated
• Start date: February 15, 2017
• Est. completion date: February 25, 2020

Study information

• Verified date: February 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Switzerland	Inselhospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunological outcome	flowcytometry	42 days
Primary	Immunological outcome	Flowcytometry	6 months
Primary	Immunological outcome	Flowcytometry	9 months
Primary	Immunological outcome	ELISA	42 days
Primary	Immunological outcome	ELISA	6 months
Primary	Immunological outcome	ELISA	9 months
Secondary	Number of local tumor recurrences	measured via CT	42 days
Secondary	Number of local tumor recurrences	measured via CT	3 months
Secondary	Number of local tumor recurrences	measured via CT	6 months
Secondary	Number of local tumor recurrences	measured via CT	9 months
Secondary	Number of distant tumor recurrences	measured via CT	42 days
Secondary	Number of distant tumor recurrences	measured via CT	3 months
Secondary	Number of distant tumor recurrences	measured via CT	6 months
Secondary	Number of distant tumor recurrences	measured via CT	9 months
Secondary	Overall survival	survival of patient	42 days
Secondary	Overall survival	survival of patient	3 months
Secondary	Overall survival	survival of patient	6 months
Secondary	Overall survival	survival of patient	9 months
Secondary	Cancer specific survival	survival of patient	42 days
Secondary	Cancer specific survival	survival of patient	3 months
Secondary	Cancer specific survival	survival of patient	6 months
Secondary	Cancer specific survival	survival of patient	9 months