Gene test may guide chemo choice for tough pancreatic cancer
NCT ID NCT05475366
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study aims to see if using five gene signatures from a patient's tumor can help doctors choose the best first chemotherapy for advanced pancreatic cancer. About 85 people with metastatic pancreatic cancer will have their tumor genes analyzed to pick between two standard chemo regimens. The main goal is to see if this personalized approach increases the number of patients whose tumors shrink significantly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy (FOLFIRINOX or Gem-nabP) chosen based on tumor gene signatures
- What this could lead to
- If successful, this could lead to a more personalized way to select chemotherapy for advanced pancreatic cancer, potentially improving how many patients respond to treatment.
- What could go wrong
- This is a small pilot study with only 85 participants, so results may not apply to everyone. The approach is experimental and may not improve outcomes or could be too complex for routine use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 85 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Dec 2028
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 75 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: 1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations. 2. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 3. Histologically or cytologically proven Pancreatic Ductal Adenocarcinoma (PDAC). 4. Metastatic disease. 5. Measurable or evaluable lesions according to RECIST v1.1 criteria. 6. First-line therapy (previous neoadjuvant/adjuvant chemotherapy not allowed). 7. Age ≥ 18 years (no upper limit, patients ≥ 75 years old must have a G8 score ≥ 14). 8. 3\. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. 9. Availability of tumor tissue sample from the primary pancreatic tumor or liver metastasis (chemo-naïve) before inclusion in step 1. 10. Adequate organ function, as defined by the following (blood test ≤ 7 days prior to inclusion): 1. Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) (≤ 5 ULN in case of liver metastases) 2. Total serum bilirubin ≤ 1.5 ULN 3. Serum albumin ≥ 28 g/L 4. Hemoglobin ≥ 9.0 g/dl 5. Absolute neutrophil count (ANC) ≥ 1,500/μL 6. Platelets ≥ 100,000/μL 7. Creatinine clearance ≥ 50 mL/min (MDRD). 11. No Dihydropyrimidine dehydrogenase (DPD) deficiency (normal uracil level). 12. Life expectancy ≥ 3 months. 13. a. Evidence of post-menopausal status b. (or) negative urinary or serum pregnancy test for female pre-menopausal patients. 14. Registration in a National Health Care System. Exclusion Criteria: 1. Concurrent enrolment in another interventional clinical study. 2. Previous treatment with chemotherapy for pancreatic cancer. 3. Uncontrolled massive pleural effusion or massive ascites. 4. Known deficiency in UGT1A1 (homozygous UGT1A1\*28 allele). 5. Active bacterial, viral, or fungal infection requiring systemic therapy, including tuberculosis, hepatitis B (known positive Hepatitis B Virus surface antigen (HBsAg) result), hepatitis C (with positive RNA), Sars-Cov-2 or human immunodeficiency virus (positive HIV 1/2 antibodies). 6. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri. 7. Known active central nervous system metastases and/or carcinomatous meningitis; patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline). 8. Uncontrolled intercurrent illness, including but not limited to, symptomatic congestive heart failure or coronary disease, peripheral artery disease, severe chronic obstructive pulmonary disease, decompensated cirrhosis, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. 9. Live vaccine administration within 30 days prior to the first dose of study treatment. 10. Known or suspected allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. 11. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the participant, in the opinion of the treating investigator. 12. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. 13. Major surgical procedure (as defined by the Investigator) within 4 weeks prior to the first dose of trial treatment. 14. Pregnancy/lactation. 15. Person under legal protection or tutelage or guardianship.
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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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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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
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Robert Debré
RECRUITINGReims, 51092, France
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Hôpital Beaujon
RECRUITINGClichy, 92210, France
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Hôpital Claude Hurriez
RECRUITINGLille, 59037, France
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Hôpital HENRI MONDOR
RECRUITINGCréteil, 94010, France
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Hôpital PAUL BROUSSE 12 Avenue Paul Vaillant Couturier
RECRUITINGVillejuif, 94800, France
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Institut Curie
RECRUITINGSaint-Cloud, 92210, France
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Institut Paoli-Calmettes
RECRUITINGMarseille, 13573, France
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