A Trial Using Transcriptomic Signatures to Personalize Neoadjuvant Chemotherapy (NAC) for Patients With Resectable Borderline Pancreatic Adenocarcinoma (PDAC)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstitut Paoli-Calmettes

About this trial

Pancreatic cancer exhibits significant heterogeneity, which poses a major challenge in selecting the best treatment for patients from the very beginning of care. Modern oncology recognizes the use of companion biomarkers to guide targeted therapy or immune checkpoint inhibitors. However, with regard to chemotherapy-which has long been the cornerstone of cancer treatment and remains crucial for most cancers-few predictive tests are available to guide the choice between monotherapy and combination chemotherapy.

Patients included in the PRODIGE 104 B - NEOPREDICT study will be those for whom the GEM transcriptomic signature is negative. This population will be treated according to the standard strategy and will be followed clinically and biologically to describe and identify the characteristics specific to this subgroup, and to compare the usual prognostic factors of this population with those of the GEM-positive population included in the parallel PRODIGE 104 A - NEOPREDICT study

Eligibility criteria

Qualifiers

Borderline-resectable pancreatic ductal adenocarcinoma (BR-PDAC) as defined by the National Comprehensive Cancer Network (NCCN) v2.2025 criteria, identified on contrast-enhanced CT scan and reviewed by a local multidisciplinary pancreatic expert board including at least a medical oncologist / onco-gastroenterologist, a pancreatic surgeon, and an expert pancreatic radiologist. No central review required.

WHO Performance Status 0-1.

Histologically confirmed pancreatic ductal adenocarcinoma, including histological variants.

Patient included-but not randomized-in the PRODIGE 104 A NEOPREDICT study due to a negative gemcitabine sensitivity signature (GEM-).

Disqualifiers

Strictly resectable or locally advanced PDAC according to NCCN criteria.

Distant metastases, including inter-aortocaval lymph nodes.

Any condition contraindicating the use of irinotecan, oxaliplatin, or 5-FU.

Complete dihydropyrimidine dehydrogenase (DPD) deficiency.

Trial design

Treatments tested in this trial

  • mFOLFIRINOX (modified FOLFIRINOX)

Treatment groups

367 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Institut Paoli-Calmettes

Lead sponsor

Federation Francophone de Cancerologie Digestive

Collaborator