PRODIGE 104 – NEOPREDICT A multicenter phase II trial using transcriptomic signatures to personalize neoadjuvant chemotherapy for patients with resectable borderline pancreatic adenocarcinoma.

Trial details

Who runs it

Fondation Franc.Cancerologie Digestive

Trial code

EU 2024-519753-11-00

Record updated

2025. október 17.

Original description

To evaluate the efficacy of treating patients with borderline resectable pancreatic ductal adenocarcinoma (BR PDAC) identified with a Gemcitabine positive sensitivity transcriptomic signature (GEM +) with GEMCITABINE + NAB-PACLITAXEL regimen compared to standard of care mFOLFIRINOX as NeoAdjuvant Chemotherapy (NAC) on event-free survival (EFS) at 1 yearRead full original descriptionShow less

To evaluate the efficacy of treating patients with borderline resectable pancreatic ductal adenocarcinoma (BR PDAC) identified with a Gemcitabine positive sensitivity transcriptomic signature (GEM +) with GEMCITABINE + NAB-PACLITAXEL regimen compared to standard of care mFOLFIRINOX as NeoAdjuvant Chemotherapy (NAC) on event-free survival (EFS) at 1 year

Inclusion: Borderline resectable pancreatic ductal adenocarcinoma (BR-PDAC) defined by National Comprehensive Cancer Network (NCCN) criteria v2.2025 on contrast-enhanced CT-scan, 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; 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; 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; Adequate organ function, as defined by the following: o AST and ALT < 3.5 x upper limit of normal (ULN), o 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). o Serum albumin >30 g/L, o Hemoglobin >9.0 g/dl, o Absolute neutrophil count (ANC) >1.5 G/L, o Platelets >100 G/L, o Creatinine clearance > 50 mL/min (according to CKD-EPI); 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.

Exclusion: Treatment with millepertuis; Treatment with brivudine within 4 weeks prior to the administration of protocol treatment; Concomitant treatment with a strong inhibitor (i.e. ketoconazole) or inducer (i.e. rifampicin, carbamazepine, phenobarbital, phenytoin, apalutamide) of cytochrome P450 3A4 or 2C8 (CYP3A4 or CYP2C8); Patient who has received a live attenuated vaccine (against yellow fever, chickenpox, shingles, measles, mumps, rubella, tuberculosis, rotavirus) in the 6 weeks prior to randomization; Known Gilbert's syndrome or known homozygosity for UGAT1A1*28 polymorphism; Potentially severe infection < 7 days; Inflammatory bowel disease and/or intestinal obstruction; Known severe allergy to contrast dye (for CT or MRI) without possible substitution; Hypersensitivity to the active substance or to one of the excipients of one of the study treatments; Any condition that contraindicates the use of IRINOTECAN, OXALIPLATIN, 5 FU, GEMCITABINE or NAB-PACLITAXEL; Any progressive pathology not stabilized over the past 6 months: liver impairment, renal impairment, respiratory or cardiac failure; Other concomitant cancer or a history of cancer during the previous 3 years, except for localized cancer in situ, basal or squamous cell skin cancer adequately treated; QT/QTc interval > 450 msec for men and > 470 msec for women; Strictly resectable or locally advanced PDAC according to NCCN criteria; Uncompensated asthma; Distant metastases (including inter aortic lymph nodes); Patient with sensitive peripheral neuropathy with functional discomfort; Impossibility of undergoing medical monitoring during the trial for geographical, social, or psychological reasons; Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent; Partial or complete DPD deficiency (uracilemia ≥ 16 ng/mL); Other interventional clinical trial except for non-interventional trial (ie not modifying 1-year EFS); Pregnant or breastfeeding woman.

EU CTIS 2024-519753-11-00