New Two-Drug sequence aims to extend life in pancreatic cancer
NCT ID NCT05065801
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 162 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Jun 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. 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.
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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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CH de Perpignan
RECRUITINGPerpignan, Pyrénées-Orientales, 66046, France
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CHU Grenoble
NOT_YET_RECRUITINGGrenoble, Auvergne-Rhône-Alpes, 38000, France
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CHU St Eloi
RECRUITINGMontpellier, Herault, 34295, France
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CHU St Etienne
ACTIVE_NOT_RECRUITINGSaint-Etienne, Auvergne-Rhône-Alpes, 42000, France
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Centre Catalan d'Oncologie
NOT_YET_RECRUITINGPerpignan, Pyrénées-Orientales, 66000, France
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Centre Georges-François Leclerc
RECRUITINGDijon, 21079, France
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Institut GODINOT
RECRUITINGReims, Grand Est, 51100, France
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Institut régional du Cancer de Montpellier
RECRUITINGMontpellier, Hérault, 34298, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo tested against aggressive pancreatic cancer
- Can a smart drug outsmart pancreatic cancer?
- Can a Triple-Drug combo outsmart pancreatic cancer?
- Can removing liver tumors alongside the whipple procedure extend life in stage IV pancreatic cancer?
- Can a One-Two punch of radiation and immunotherapy tame pancreatic cancer?
- Can a Two-Drug immune attack shrink Hard-to-Treat pancreatic tumors?