To determine the local and systemic immune profile, with emphasis on T lymphocytes, in pancreatic cancer patients; and monitor how these immune profiles are affected by treatment for individual patients.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
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 monitor the effect of treatment (neoadjuvant CRTx, adjuvant chemotherapy
or palliative chemotherapy) on the expression of co-inhibitory molecules and
their ligands on TIL and PB lymphocytes.
Background summary
Patients 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 therapy 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 current treatment modalities.
Study objective
To determine the local and systemic immune profile, with emphasis on T
lymphocytes, in pancreatic cancer patients; and monitor how these immune
profiles are affected by treatment for individual patients.
Study design
Multicenter prospective cohort study
Intervention
Whole blood will be collected from 100 pancreatic cancer patients. A small part
of tumor will be stored for analysis from patients who will undergo a resection.
During the course of the study blood will be collected multiple times. The
number of blood collections depends on the exact diagnosis:
- resectable and borderline resectabele pancreatic cancer, maximum of 11
collections during a maximum period of 30 weeks
- locally advanced pancreatic cancer, maximum of 5 collections during a maximum
period of 40 weeks
- metastatic pancreatic cancer, maximum of 4 collections during a maximum
period of 17 weeks
An immune profile will be determined for each timepoint. This will enable us to
track changes in the immune system during the whole treatment course of the
individual patient. This will make it possible to detect changes related to
treatment interventions, e.g. chemotherapy. In the future we could possible
adapt treatment guidelines in such a way that we can optimize the function of
the immune system during the course of treatment.
Study burden and risks
Intervention
- resectable and borderline resectabele pancreatic cancer, maximum of 10
collections (200 ml whole blood) during a maximum period of 1 year
- locally advanced pancreatic cancer receiving FOLFIRINOX, SBRT and resection,
maximum of 10 collections (200 ml whole blood) during a maximum period of 40
weeks
- - locally advanced pancreatic cancer only receiving SBRT, maximum of 5
collections (300 ml whole blood) during a maximum period of 25 weeks
- metastatic pancreatic cancer, maximum of 4 collections (80 ml whole blood)
during a maximum period of 17 weeks
- pancreatic cancer patients receiving immunotherapy on a named patient basis
(e.g. Ampligen®) or DC therapy, maximum of 4 collections (80 ml whole blood)
during a maximum period of 18 weeks
- patienst who have been treated with dendritic ell therapy, maximum of 1
collection (20 ml) after treatment completion.
Risks
There are considered to be no extra risks in participating in this study.
Benefit
We expect that in the future patients diagnosed with pancreatic cancer can
benefit from the results of this research.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
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 currently available standard of care treatments
for pancreatic cancer (e.g. surgery, gemcitabine, neoadjuvant
chemoradiotherapy, FOLFIRINOX and/or (stereotactic) radiotherapy) or new
treatment options such as, but not limited to, Ampligen® (immunotherapy) or DC
therapy.
• 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL59131.078.16 |
| OMON | NL-OMON27380 |