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Tailored chemo after surgery could boost pancreatic cancer survival

NCT ID NCT07044453

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving different chemotherapy drugs after pancreatic cancer surgery, based on how much tumor remains, can improve survival. About 390 patients who received chemo before surgery will be randomly assigned to one of two drug regimens. The goal is to reduce cancer recurrence and extend life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gemcitabine with Nab-Paclitaxel or mFOLFIRINOX (chemotherapy drugs)
What this could lead to
If successful, this could lead to a more personalized chemotherapy plan after pancreatic cancer surgery, potentially reducing recurrence and improving survival.
What could go wrong
This is an early-phase trial (Phase 2/3) with only 390 participants, so results may not apply to all patients. Chemotherapy side effects can be severe, and the approach may not significantly improve outcomes.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 390 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2032

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed resected pancreatic adenocarcinoma (R0 or R1) that has received 3 months of neoadjuvant mFOLFIRINOX, including anatomically resectable and borderline resectable tumors, in accordance with the definitions and therapeutic considerations provided in the TNCD (2024) and ESMO (2023) guidelines. 2. Performance status ECOG 0 or 1 3. CA 19-9 level ≤ 200 U/ml 4. Age 18 years or over 5. Absolute neutrophil count \> 1,500 mm³, platelet count \> 100,000 mm³, creatinine clearance (according to MDRD equation) \> 50 ml/min, haemoglobin level \> 10 g/dl (transfusions are authorized) 6. Women of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile): with highly effective contraception (Cf. CTCG): combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence) since 1 month, during chemotherapy treatment and for 15 months after cessation of chemotherapy treatment, and a negative blood pregnancy test for β-HCG at inclusion as well as pregnancy tests before each cycle of adjuvant chemotherapy, then monthly throughout the study until 15 months after the end of exposure to systemic treatment. Women permanently sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy). Postmenopausal women: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. 7. For men participating in the study, contraception is required during the trial and for 12 months after stopping chemotherapy treatment. 8. Patient affiliated with, or beneficiary of, a social security (national health insurance) plan 9. Patient able to comply with the study protocol, in the investigator's judgment 10. Read and understood the information letter and signed the consent form Exclusion Criteria: 1. Metastatic PAC on post-operative imaging 2. Cholangiocarcinoma, ampullary carcinoma or other non-PAC pancreatic tumors 3. Non-controlled congestive heart failure, non-treated angina, recent myocardial infarction (in the previous year), non-controlled AHT (SBP \> 160 mm Hg or DBP \> 100 mm Hg, despite optimal drug treatment), long QT 4. Major non-controlled infection, chronic infectious diseases, immune deficiency syndromes 5. Premalignant hematologic disorders, e.g. myelodysplastic syndrome 6. Severe liver failure 7. Past or current history of malignancies except for the indication under this study and curatively treated basal and squamous cell carcinoma of the skin, in situ carcinoma of the cervix, other malignant disease without recurrence after at least 2 years of follow-up 8. Any medical, psychological or social situation that (in the investigator's opinion) could limit the patient's compliance with the protocol or the ability to obtain or interpret data or to understand the conditions required for his/her participation in the protocol or render him/her unable to give informed consent 9. Pregnant or breastfeeding women and women of childbearing age not using effective means of contraception 10. Person participating in another interventional research having the same primary endpoint 11. Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship 12. Uracilemia ≥ 150 ng/ml (suggestive of complete DPD deficiency) 13. Contraindication to study adjuvant chemotherapy treatments in accordance with the SmPCs of the products used in this trial (Gemcitabine, Nab-Paclitaxel, Oxaliplatin, Folinic Acid or Leucovorin, Irinotecan, Fluorouracil)

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CHU de Rouen

    RECRUITING

    Rouen, France

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