Personalize (Signature Driven) Neoadjuvant Chemotherapy Trial for Patients With Resectable Borderline Pancreatic Ductal Adenocarcinoma.

Inclusion Criteria

• •Borderline resectable pancreatic ductal adenocarcinoma (BR-PDAC) defined by National Comprehensive Cancer Network (NCCN) criteria v2.2025 on contrast-enhanced CT-scan (including non-contrast acquisition, pancreatic phase and portal venous phase), with stage confirmed by a local pancreatic expert review board including at least medical oncologist/onco-gastroenterologist, pancreatic surgeon and pancreatic expert radiologist. No central review is required,
• •Measurable pancreatic lesion according to RECIST 1.1 (CT scan or MRI \< 28 days),
• •WHO PS 1 or 0,
• •Histologically proven pancreas ductal adenocarcinoma,
• •Available FFPE from pancreatic tumor sample with \> 10% of tumor cells (assessed by a local expert pancreatic pathologist),
• •No prior chemotherapy or radiation for pancreatic cancer (except one cycle of mFOLFIRINOX during waiting time for GEM + signature) or resection of pancreatic cancer,
• •Age ≥18 years old and ≤ 80 years old if geriatric standardized evaluation validates the study chemotherapy regimen administration for patients between 75-80,
• •Written informed consent obtained from patient before any protocol related intervention,
• •Acceptation and ability to conform to the protocol requirement during all the duration of the investigation including treatment, scheduled visits, clinical and biological examinations and follow up,
• •Adequate organ function, as defined by the following:
• •AST and ALT \< 3.5 x upper limit of normal (ULN),
• •Total serum bilirubin \< 3 x ULN, (for patients with total serum bilirubin between 1.5 and 3 x ULN, the dose of irinotecan will be adjusted in accordance with the SmPC).
• •Serum albumin \>30 g/L,
• •Hemoglobin \>9.0 g/dl,
• •Absolute neutrophil count (ANC) \>1.5 G/L,
• •Platelets \>100 G/L,
• •Creatinine clearance \> 50 mL/min (according to CKD-EPI),
• •Normal Kalemia, calcemia, magnesemia
• •Women of childbearing potential must agree to use contraception during treatment and for at least 15 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 12 months after discontinuation of the experimental treatments.
• •Patient affiliated to French social security