Pancreatic Cancer Clinical Trial
Official title:
PD-L1 and MMR Status Provided by Endoscopic Ultrasound-Guided Fine-Needle Biopsies as a Predictor of PrognosiS in Patients With Pancreatic Ductal Adenocarcinoma
Pancreatic ductal adenocarcinoma (PDAC) has a suboptimal response to standard therapies that
modestly impact survival due to its ability to evade host immune surveillance. Emerging
evidence has shown that the co-inhibitory receptors, such as programmed death 1 (PD-1), play
a critical role in cancer immune-editing. Programmed death-ligand 1 (PD-L1) is an immune
checkpoint that is often activated in cancer and plays a pivotal role in the initiation and
progression of cancer. The advent of immunotherapy, with checkpoint inhibitors, which block
PD-L1 interaction between tumor cells and activated T cells, has significantly altered the
treatment algorithm for several solid tumors.
However, the clinicopathologic significance and prognostic value of PD-L1 in PDAC remains
controversial. The main technical ground may be that PDAC PD-L1 expression quantification is
limited to surgical resection specimens and dependent on specific immunohistochemistry (IHC)
tests. In addition, PD-L1 expression has not been extensively assessed before surgery in
treatment-naive PDAC patients, due to the current IHC test requirement for a histologic
rather than a cytologic evaluation. However, a recent study showed that EUS-fine needle
biopsy (FNB) can successfully determine primary pancreas malignancy PD-L1 status.
One recently identified subtype within the genomic landscape of PDAC is the mismatch
repair-deficient (dMMR) tumor. Evaluation of dMMR status is particularly important following
the FDA approval of the PD-1 inhibitor, pembrolizumab, for the treatment of unresectable or
metastatic, microsatellite instability-high (MSI-H) or dMMR PDAC that have progressed
following prior treatment, and have no satisfactory alternative treatment options.
The objectives of the project will include the assessment of tumor PD-L1/dMMR expression in
patients with PDAC using EUS-FNB samples and the prospective correlation of MMR status and
PD-L1 expression with overall survival and progression-free survival of PDAC patients.
n/a
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