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New Two-Drug sequence aims to extend life in pancreatic cancer

NCT ID NCT05065801

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving two different chemotherapy combinations one after the other works better than the standard single combination for people with metastatic pancreatic cancer. About 162 adults aged 18 to 75 with confirmed disease will be randomly assigned to either the sequential treatment or the standard alone. The main goal is to see which approach delays cancer growth longer.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 162 people

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

Started

Jan 2022

Expected to finish

Jun 2028

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 to 75 years

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. Male or female aged 18 to 75 on the date the consent is signed. 2. Histologically or cytologically proven metastatic pancreatic adenocarcinoma. The definitive diagnosis of pancreatic adenocarcinoma metastases will be made by integrating the histopathological data in the context of the radiological data. 3. One or more metastatic lesion (s) measurable (Recist 1.1) by Thoraco-Abdomino-Pelvic scanner (or hepatic MRI and Thoraco-Abdomino-Pelvic scanner not injected, if the patient is allergic to the product of contrast). 4. Previous treatment (including radiochemotherapy) for the non-metastatic disease authorized if a delay ≥ 6 months between the last treatment and the recurrence is respected. 5. WHO performance status ≤ 1 6. Uracilemia \<16 ng / ml 7. Acceptable hematological assessment at inclusion (obtained within 14 days before the start of treatment) defined by: • Neutrophils ≥ 2 × 109 / L; • Platelets ≥ 100,000 / mm3 (100 × 109 / L); • Hemoglobin ≥ 9 g / dl. 8. Acceptable renal and hepatic function at inclusion (obtained within 14 days before the start of treatment) defined by: • AST and ALT ≤ 2.5 x upper limit of the norm (ULN), unless liver metastases are present in this case AST and ALT ≤ 5 × ULN is allowed; • Total bilirubin ≤ 1.5 x ULN; • Serum creatinine within the norm limits or calculated clearance ≥ 50ml / min for patients with a serum creatinine value above or below the norm values (clearance calculated by the CKD-EPI formula). 9. Calcemia AND magnesemia AND kalaemia ≥ LLN and ≤ 1.2 x ULN 10. If the patient is sexually active, he must agree to use contraception deemed adequate and appropriate by the investigator throughout the period of administration of the study drug and up to 6 months after discontinuation of treatment for women and for men. 11. Signature of consent before any procedure specific to the study. 12. Affiliated with the French national social security. Exclusion Criteria: 1. Known brain metastasis. 2. Previous treatment with radiotherapy, surgery, chemotherapy or experimental therapy for the treatment of metastatic disease. 3. Major surgery, other than diagnostic surgery (that is, surgery done to obtain a diagnostic biopsy without organ harvesting), within 4 weeks of day 1 of study treatment. 4. Known Gilbert's syndrome or homozygous for know UGT1A1 \* 28 5. Other concomitant cancer or history of cancer, except cervical cancer in situ treated, skin basal or squamous cell carcinoma, superficial bladder tumor (Ta, Tis, and T1) or a tumor with a good prognosis treated curatively without chemotherapy and without any sign of disease in the 3 years preceding inclusion. 6. Patients with high cardiovascular risk, including, but not limited to, coronary stent or myocardial infarction within the past 6 months. 7. Peripheral sensory neuropathy ≥ grade 2 at the time of inclusion. 8. ECG with a QTc interval greater than 450 ms for men and greater than 470 ms for women 9. Any other concomitant and unbalanced disease or serious disturbance that may interfere with the patient's participation in the study and his safety during the study (eg severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders) 10. Allergy or intolerance to any study drug (gemcitabine, nab-paclitaxel, oxaliplatin, irinotecan, 5-FU) or any excipient (e.g., fructose) as described in the sections " contraindication or special warnings and precautions" or "prescribing information" of the summary of product characteristics indications. 11. Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test (serum β-hCG) within 72 hours prior to inclusion. 12. Patients on vitamin K antagonists (e.g., Coumadin) (modifications to treatment may be required prior to inclusion). 13. Treatment with brivudine within 4 weeks before or after treatment with 5-fluorouracil (due to a potentially fatal interaction). 14. Active and uncontrolled bacterial, viral, or fungal infections requiring systemic treatment. 15. Active HIV infection, known hepatitis B or C infection. 16. History of peripheral arterial disease (e.g., claudication, Buerger's disease), chronic inflammatory bowel disease or rectal disease, pulmonary fibrosis or interstitial pneumonia. 17. Administration of a live attenuated vaccine within 10 days before inclusion and up to 6 months post-treatment. 18. Patient refusal or inability to comply with study procedures. 19. Inability to undergo follow-up for geographical, social, or psychological reasons. 20. Participation in another clinical trial involving an investigational product within the 30 days prior to inclusion. 21. Legal incapacity (patient under guardianship 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.

  1. The places running it

    7 sites. 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

  • CH de Perpignan

    RECRUITING

    Perpignan, Pyrénées-Orientales, 66046, France

  • CHU Grenoble

    NOT_YET_RECRUITING

    Grenoble, Auvergne-Rhône-Alpes, 38000, France

  • CHU St Eloi

    RECRUITING

    Montpellier, Herault, 34295, France

  • CHU St Etienne

    ACTIVE_NOT_RECRUITING

    Saint-Etienne, Auvergne-Rhône-Alpes, 42000, France

  • Centre Catalan d'Oncologie

    NOT_YET_RECRUITING

    Perpignan, Pyrénées-Orientales, 66000, France

  • Centre Georges-François Leclerc

    RECRUITING

    Dijon, 21079, France

  • Institut GODINOT

    RECRUITING

    Reims, Grand Est, 51100, France

  • Institut régional du Cancer de Montpellier

    RECRUITING

    Montpellier, Hérault, 34298, France

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