No registrations found.
ID
Source
Brief title
Health condition
Pancreatic ductal adenocarcinoma (PDAC)
Sponsors and support
Intervention
Outcome measures
Primary outcome
The level of PDAC-specific oncolytic activity of vermiform appendix derived T lymphocytes
Secondary outcome
Identification of
- PDAC specific antigens
- appendix fecal microbiome diversity
- molecular immune landscapes in the vermiform appendix sana from patients with PDAC compared to controls
- differential T-cell and B-cell receptor repertoires in peripheral blood lymphocytes vs lymphocytes from the vermiform appendix, in patients with PDAC.
Background summary
Pancreatic ductal adenocarcinoma (PDAC) is notorious for its immune-suppressive tumor microenvironment, low numbers of intratumoral cytotoxic T-cells (CTLs) which
are often functionally exhausted and its poor immune checkpoint inhibitor response.
Our preclinical studies performed in immune competent PDAC mouse models have shown that gut associated lymphoid tissue (GALT) represents a potential source for pancreatic cancer specific CTLs that are not functionally suppressed or exhausted.
The APPART single center translational pilot study is designed to investigate the molecular properties and anti-tumor cytolytic function of T-lymphocytes isolated from the vermiform appendix sana of PDAC patients.
The APPART study may open up doors for T-cell transfer therapy and improvement of immune therapy for PDAC.
Study objective
We hypothesize that tumor antigens are presented to naïve T-lymphocytes in the gut associated lymphoid tissue of the vermiform appendix to induce differentiation to cytotoxic T cells in patients with PDAC.
Study design
Three time points: plasma and PBMCs before appendectomy; mononuclear cells from the appendix; PBMCs after appendectomy
Intervention
Peripheral venous blood draws, appendectomy during standard of care (laparoscopic) surgery, liver and peritoneal biopsies if metastases are visualized during staging laparoscopy
Inclusion criteria
Patients aged 18 years or older with treatment naïve pancreatic ductal adenocarcinoma who will either undergo staging laparoscopy for locally advanced disease, or tumor resection for (borderline) resectable disease.
Exclusion criteria
prior appendectomy, prior malignancy within the past 5 years, prior chemotherapy or radiotherapy within the past 5 years, pregnancy, participation in the PREOPANC-2 trial.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7553 |
| Other | METC Erasmus Medisch Centrum : MEC-2018-1510 |