Pancreatic CancerIRE ImmunoNCT03069599
Immune Response After Pancreatic Cancer Treatment
An observational study of Pancreatic Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- irreversible electroporation (IRE)
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Feb 2017to 25 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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?
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
- Being tested
- irreversible electroporation (IRE)
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irreversible electroporation (IRE)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 10 IRE locally advanced | patients undergoing in situ IRE for locally advanced pancreatic Receives: Procedure: irreversible electroporation (IRE) | |
| 10 IRE borderline resection | patients undergoing margin accentuation IRE for borderline resectable disease Receives: Procedure: irreversible electroporation (IRE) | |
| 10 resection only | patients undergoing surgical resection only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological outcome
flowcytometry
Measured: 42 days
Immunological outcome
Flowcytometry
Measured: 6 months
Immunological outcome
Flowcytometry
Measured: 9 months
Immunological outcome
ELISA
Measured: 42 days
Immunological outcome
ELISA
Measured: 6 months
Immunological outcome
ELISA
Measured: 9 months
Secondary outcomes (16)
Number of local tumor recurrences
measured via CT
Measured: 42 days
Number of local tumor recurrences
measured via CT
Measured: 3 months
Number of local tumor recurrences
measured via CT
Measured: 6 months
Number of local tumor recurrences
measured via CT
Measured: 9 months
Number of distant tumor recurrences
measured via CT
Measured: 42 days
Number of distant tumor recurrences
measured via CT
Measured: 3 months
Number of distant tumor recurrences
measured via CT
Measured: 6 months
Number of distant tumor recurrences
measured via CT
Measured: 9 months
Overall survival
survival of patient
Measured: 42 days
Overall survival
survival of patient
Measured: 3 months
Overall survival
survival of patient
Measured: 6 months
Overall survival
survival of patient
Measured: 9 months
Cancer specific survival
survival of patient
Measured: 42 days
Cancer specific survival
survival of patient
Measured: 3 months
Cancer specific survival
survival of patient
Measured: 6 months
Cancer specific survival
survival of patient
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start15 Feb 2017
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Why it stopped: PI left hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathias Worni, MD, Principal investigator, Inselspital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069599
- Sponsor's protocol ID
- 2016-02037
- Other IDs
- 2016
- Acronym
- IRE Immuno
- Status last verified
- Feb 2020
- First submitted
- 20 Dec 2016
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT03069599
- Acronym / sponsor ID
- IRE Immuno / 2016-02037
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left hospital
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 IRE locally advanced | – | Procedure: irreversible electroporation (IRE)patients undergoing in situ IRE for locally advanced pancreatic |
| 10 IRE borderline resection | – | Procedure: irreversible electroporation (IRE)patients undergoing margin accentuation IRE for borderline resectable disease |
| 10 resection only | – | –patients undergoing surgical resection only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | 10 IRE borderline resection, 10 IRE locally advanced |
Primary outcome
Immunological outcome
Time frame: 42 days
flowcytometry
Immunological outcome
Time frame: 6 months
Flowcytometry
Immunological outcome
Time frame: 9 months
Flowcytometry
Immunological outcome
Time frame: 42 days
ELISA
Immunological outcome
Time frame: 6 months
ELISA
Immunological outcome
Time frame: 9 months
ELISA
16 secondary outcomes
Number of local tumor recurrences
Time frame: 42 days
Number of local tumor recurrences
Time frame: 3 months
Number of local tumor recurrences
Time frame: 6 months
Number of local tumor recurrences
Time frame: 9 months
Number of distant tumor recurrences
Time frame: 42 days
Number of distant tumor recurrences
Time frame: 3 months
Number of distant tumor recurrences
Time frame: 6 months
Number of distant tumor recurrences
Time frame: 9 months
Overall survival
Time frame: 42 days
Overall survival
Time frame: 3 months
Overall survival
Time frame: 6 months
Overall survival
Time frame: 9 months
Cancer specific survival
Time frame: 42 days
Cancer specific survival
Time frame: 3 months
Cancer specific survival
Time frame: 6 months
Cancer specific survival
Time frame: 9 months
Results and safety
The study was stopped early (reason given: PI left hospital). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Worni, MD principal investigator
Inselspital Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left hospital). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological outcome (time frame: 42 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.