Immune Response After Pancreatic Cancer Treatment (IRE Immuno)
25 februari 2020 uppdaterad av: University Hospital Inselspital, Berne
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
38
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
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Bern, Schweiz
- Inselhospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
10 IRE locally advanced
patients undergoing in situ IRE for locally advanced pancreatic
|
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.
|
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10 IRE borderline resection
patients undergoing margin accentuation IRE for borderline resectable disease
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Immunological outcome
Tidsram: 42 days
|
flowcytometry
|
42 days
|
|
Immunological outcome
Tidsram: 6 months
|
Flowcytometry
|
6 months
|
|
Immunological outcome
Tidsram: 9 months
|
Flowcytometry
|
9 months
|
|
Immunological outcome
Tidsram: 42 days
|
ELISA
|
42 days
|
|
Immunological outcome
Tidsram: 6 months
|
ELISA
|
6 months
|
|
Immunological outcome
Tidsram: 9 months
|
ELISA
|
9 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of local tumor recurrences
Tidsram: 42 days
|
measured via CT
|
42 days
|
|
Number of local tumor recurrences
Tidsram: 3 months
|
measured via CT
|
3 months
|
|
Number of local tumor recurrences
Tidsram: 6 months
|
measured via CT
|
6 months
|
|
Number of local tumor recurrences
Tidsram: 9 months
|
measured via CT
|
9 months
|
|
Number of distant tumor recurrences
Tidsram: 42 days
|
measured via CT
|
42 days
|
|
Number of distant tumor recurrences
Tidsram: 3 months
|
measured via CT
|
3 months
|
|
Number of distant tumor recurrences
Tidsram: 6 months
|
measured via CT
|
6 months
|
|
Number of distant tumor recurrences
Tidsram: 9 months
|
measured via CT
|
9 months
|
|
Overall survival
Tidsram: 42 days
|
survival of patient
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42 days
|
|
Overall survival
Tidsram: 3 months
|
survival of patient
|
3 months
|
|
Overall survival
Tidsram: 6 months
|
survival of patient
|
6 months
|
|
Overall survival
Tidsram: 9 months
|
survival of patient
|
9 months
|
|
Cancer specific survival
Tidsram: 42 days
|
survival of patient
|
42 days
|
|
Cancer specific survival
Tidsram: 3 months
|
survival of patient
|
3 months
|
|
Cancer specific survival
Tidsram: 6 months
|
survival of patient
|
6 months
|
|
Cancer specific survival
Tidsram: 9 months
|
survival of patient
|
9 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Mathias Worni, MD, Inselspital Berne
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 februari 2017
Primärt slutförande (Faktisk)
25 februari 2020
Avslutad studie (Faktisk)
25 februari 2020
Studieregistreringsdatum
Först inskickad
20 december 2016
Först inskickad som uppfyllde QC-kriterierna
2 mars 2017
Första postat (Faktisk)
3 mars 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 februari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 februari 2020
Senast verifierad
1 februari 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2016-02037
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