Pancreatic ductal adenocarcinoma (PDAC) exhibits significant heterogeneity, making the optimal choice of chemotherapy challenging. While targeted therapies benefit from companion biomarkers, few tools exist to guide the selection of cytotoxic chemotherapy. Transcriptomic signatures now allow for the prediction of sensitivity to cytotoxic agents. Several molecular classifications (such as basal-like, classical, etc.) have been established and correlated with prognosis, but they are rarely used in clinical practice. The PaCaOmics program has developed robust predictive signatures, grouped under the name Pancreas-View Signature, capable of analyzing FFPE samples using minimal material.
Locally advanced or borderline resectable pancreatic cancer (BR-PDAC) accounts for approximately 20% of cases. Neoadjuvant chemotherapy (NAC) has become the standard of care, improving R0 resection rates and overall survival. The two main chemotherapy regimens used are mFOLFIRINOX and GEM/NAB-paclitaxel, which show comparable efficacy and toxicity profiles. However, no clear consensus exists on the superiority of one over the other. Therefore, predictive biomarkers are crucial to help select the most appropriate neoadjuvant regimen, avoid unnecessary toxicities, and maximize the chances of curative surgery. The NEOPREDICT trial aims to evaluate the efficacy of treating patients with borderline resectable PDAC identified with a GEM+ sensitivity transcriptomic signature with GEMCITABINE + NAB-PACLITAXEL regimen compared to standard of care mFOLFIRINOX as NAC.
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,
Strictly resectable or locally advanced PDAC according to NCCN criteria,
Distant metastases (including inter aortic lymph nodes),
Any condition that contraindicates the use of IRINOTECAN, OXALIPLATIN, 5FU, GEMCITABINE or NAB-PACLITAXEL,
Partial or complete DPD deficiency (uracilemia ≥ 16 ng/mL),
Parallel
Nab paclitaxel / gemcitabine
DrugNAB-PACLITAXEL 125 mg/m2 (30 min infusion) on day 1, 8 and 15. GEMCITABINE 1000 mg/m2 over 30 min infusion on day 1, 8 and 15.
mFOLFIRINOX
DrugOxaliplatin 85 mg/m2 as a 2-hour IV infusion on day 1. Folinic acid 400 mg/m2 (or Leucovorin 200 mg/m²) as a 2-hour IV infusion (after end of oxaliplatin), in Y with irinotecan on day 1. Irinotecan 180 mg/m2 (150 mg/m2 for older patient after SGA) for 1h30 on day 1 (30 min after beginning of folinic acid). 5-FU 2400 mg/m2 as a continuous IV infusion over 46 hours, from day 1.
Event Free Survival
Event Free Survival (EFS) will be calculated from the date of randomization to the date at which the first event occurs. Patients alive without any event will be censored at the date of last news.Events to be considered for the endpoint will be: Disease progression, No pancreatic resection (all causes), Death whatever the cause, Grade IV febrile neutropenia or grade IV diarrhea during NAC.
Objectif Response Rate (ORR)
Objective Response rate (ORR) will be evaluated with RECIST 1.1 criteria by the investigator regarding the scans during the NAC. The objective response rate is defined as % of patients with a complete or a partial response.
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