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

NCT07592819 | Not Yet Recruiting

• 1 other identifier: PRODIGE 104 B-NEOPREDICT-IPC 2
• Study Type: interventional
• Target: 367
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Pancreatic Cancer Resectable; Pancreas Adenocarcinoma (MSI-H)

Keywords

Transcriptomic-guided chemotherapy; Borderline-resectable pancreatic cancer; Predictive biomarker validation

Outcome Measures

Primary Outcomes (1)

• 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.

  From treatment initiation through 1 year

Secondary Outcomes (13)

• Objective Response Rate (ORR)

  During neoadjuvant chemotherapy (up to 16 weeks)

• Overall Survival (OS)

  From treatment initiation through study completion (up to 18 months)

• Progression-Free Survival (PFS)

  From treatment initiation through study completion (up to 18 months)

• Recurrence-Free Survival (RFS)

  From treatment initiation through study completion (up to 18 months)

• Disease Control Rate (DCR)

  During neoadjuvant chemotherapy (up to 16 weeks)

Study Arms (1)

single arm - mFOLFIRINOX

EXPERIMENTAL

Patients GEM- with BR-PDAC receiving standard mFOLFIRINOX according to clinical guidelines.

Drug: mFOLFIRINOX (modified FOLFIRINOX)

Interventions

mFOLFIRINOX (modified FOLFIRINOX) DRUG

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.

single arm - mFOLFIRINOX

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead
• Federation Francophone de Cancerologie Digestive: collaborator

Central Study Contacts

PAKRADOUNI

CONTACT

+33 4 91 22 37 78; drci.up@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: May 18, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): November 1, 2031
• Last Updated: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share