Gene test could tailor chemo for tough pancreatic cancers
NCT ID NCT07592819
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to see if using a patient's genetic signature to choose chemotherapy can improve outcomes for people with borderline resectable pancreatic cancer. About 367 participants will receive standard chemotherapy, and researchers will track how long they live without major complications. The goal is to better understand which treatments work best for different genetic profiles.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 367 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Other studies related to the condition(s) this trial covers.
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