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
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-).
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.
Single group
mFOLFIRINOX (modified FOLFIRINOX)
DrugPatients with borderline resectable pancreatic ductal adenocarcinoma (BR-PDAC) who are negative for the gemcitabine sensitivity transcriptomic signature (GEM-) receive neoadjuvant mFOLFIRINOX chemotherapy as standard of care. This observational cohort follows patients prospectively without modifying routine management.
Primary Outcome Measure
Event-Free Survival is defined as the time from the start of treatment to the occurrence of any of the following events: * disease progression, * failure to undergo pancreatic resection, * death from any cause, * grade IV febrile neutropenia or grade IV diarrhea occurring during neoadjuvant chemotherapy. Participants without an event will be censored at the date of last follow-up.
Objective Response Rate (ORR)
Percentage of participants achieving a complete response or partial response per RECIST 1.1 criteria.
Overall Survival (OS)
Time from start of treatment to death from any cause.
Progression-Free Survival (PFS)
For non-operated patients: time from treatment initiation to disease progression or death from any cause.
Recurrence-Free Survival (RFS)
For operated patients: time from treatment initiation to first local or metastatic recurrence or death.
Click on the lead sponsor to view all of their trials.
Institut Paoli-Calmettes
Lead sponsor
Federation Francophone de Cancerologie Digestive
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
