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Immune monitoring in pancreatic cancer


- candidate number25671
- NTR NumberNTR6320
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-dec-2016
- Secondary IDsNL59131.078.16  
- Public TitleImmune monitoring in pancreatic cancer
- Scientific TitleImmune monitoring in pancreatic cancer
- ACRONYM
- hypothesisanalysis of the systemic (blood) and local (tumor tissue) immune parameters in patients with pancreatic cancer and during conventional therapies could reveal new insights in the interplay of these treatment modalities with the immune system and provide a basis/rationale for new (immuno)therapeutic approaches and combination therapies.
- Healt Condition(s) or Problem(s) studiedPancreas tumor
- Inclusion criteria•Age ≥ 18 years
•Diagnosed with resectable or borderline resectable pancreatic cancer, locally advanced pancreatic cancer or metastasized pancreatic cancer
•Planned treatment with either of the currently available standard of care treatments for pancreatic cancer (e.g. surgery, gemcitabine, FOLFIRINOX and/or radiotherapy)
•Signed informed consent
- Exclusion criteria•Unable to draw blood for study purposes
•Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2016
- planned closingdate1-okt-2018
- Target number of participants200
- InterventionsBlood collection
- Primary outcome•To determine the baseline immune signature in pancreatic cancer patients.
- Secondary outcome•To investigate whether the immune profile found in the PB reflects the local immune signature of the pancreatic tumor.
•To determine the effect of standard of care treatment (neoadjuvant CRTx, adjuvant chemotherapy or palliative chemotherapy) on the expression of co-inhibitory molecules and their ligands on TIL and PB lymphocytes.
- TimepointsIn general we will obtain a baseline sample from every patient (e.g. before surgery or before start of treatment) followed by several samples during their treatment course based on start of therapy and follow-up after each cycle of CTx and/or RTx (maximized at 11 timepoint in total).
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. dr. C.H.J. van Eijck
- CONTACT for SCIENTIFIC QUERIES Judith Verhagen
- Sponsor/Initiator Foundation for Liver and Gastrointestinal Research
- Funding
(Source(s) of Monetary or Material Support)
Foundation for Liver and Gastrointestinal Research
- Publications
- Brief summaryPatients diagnosed with pancreatic cancer have a poor survival. There is a strong need for new therapeutic approaches. The presence of pancreatic cancer is known to affect the functionality of the immune system and furthermore chemotherapy (CTx) and (chemo)radiotherapy (CRTx) can subvert immunosuppressive mechanisms, or elicit immune responses by immunogenic cell death of cancer cells. In depth analysis of the systemic (blood) and local (tumor tissue) immune parameters in patients with pancreatic cancer and during conventional therapies could reveal new insights in the interplay of these treatment modalities with the immune system and provide a basis/rationale for new (immuno)therapeutic approaches and combination therapies, e.g. including immune checkpoint blockade, adoptive immune therapies, Toll like receptors agonist and interferons in the current standard of care treatments.
- Main changes (audit trail)
- RECORD20-dec-2016 - 26-mei-2017


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