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NCT07592819

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

Sponsor: Institut Paoli-Calmettes

View on ClinicalTrials.gov

Summary

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

Official title: A Multicenter Randomized Phase II Trial Using Transcriptomic Signatures to Personalize Neoadjuvant Chemotherapy (NAC) for Patients With Resectable Borderline Pancreatic Adenocarcinoma (PDAC)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

367

Start Date

2026-05

Completion Date

2031-11

Last Updated

2026-05-18

Healthy Volunteers

Conditions

Pancreas Adenocarcinoma (MSI-H)Pancreatic Cancer Resectable

Interventions

DRUG

mFOLFIRINOX (modified FOLFIRINOX)

Patients 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.

Inclusion Criteria: * 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-). * Negative gemcitabine transcriptomic signature (test centrally performed in PRODIGE 104 A NEOPREDICT). * No prior chemotherapy or radiotherapy for pancreatic cancer, and no previous definitive pancreatic cancer resection (except one cycle of mFOLFIRINOX administered while awaiting the signature result). * Age \> 18 years and \< 80 years, with the possibility to include patients aged 75-80 if a standardized geriatric assessment confirms eligibility for the study chemotherapy regimen. * Ability and willingness to comply with protocol requirements during the entire study period (treatment, scheduled visits, clinical and biological examinations, follow-up). * Patient's non-opposition to participation in the study. * Affiliation to the French national health insurance system. Exclusion Criteria: * 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. * Any uncontrolled or unstable medical condition within the past 6 months (e.g., hepatic, renal, respiratory, or cardiac insufficiency). * Another concomitant malignancy or history of cancer within the past 3 years, except for adequately treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma. * Pregnancy or breastfeeding. * Patients under legal protection, guardianship, curatorship, or under judicial/administrative protection. * Patients receiving psychiatric care or unable to provide consent. * Inability to comply with medical follow-up for geographical, social, or psychological reasons.