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NCT07592819Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 18 May 2026

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
367 (estimated)
First submitted
1 Apr 2026
Start date
May 2026
Primary completion date
May 2030
Lead sponsor
Institut Paoli-Calmettes
NCT number
NCT07592819

What you commit to

  • Study type: Interventional
  • Planned participants: 367
  • From May 2026 to the primary completion date, May 2030
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients receiving psychiatric care or unable to provide consent.

Other illness

  • Any condition contraindicating the use of irinotecan, oxaliplatin, or 5-FU.
  • 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.

Other

  • Strictly resectable or locally advanced PDAC according to NCCN criteria.
  • Distant metastases, including inter-aortocaval lymph nodes.
  • Complete dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Pregnancy or breastfeeding.
  • Patients under legal protection, guardianship, curatorship, or under judicial/administrative protection.
  • Inability to comply with medical follow-up for geographical, social, or psychological reasons.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.