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Gemcitabine plus Nab-PAclitaxel as switch maiNTEnance versus cONtinuation of modified FOLFIRINOX as first-line chemotherapy in patients with advanced pancreatic cancer: the PANThEON phase III trial

NCT ID NCT06897644

NEW Sponsor: Gruppo Oncologico del Nord-Ovest Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 09, 2026

Summary

PANThEON is a randomized, open-label, multicenter phase III trial aimed at comparing the switch maintenance with gemcitabine plus nab-paclitaxel (ARM B) versus mFOLFIRINOX continuation (ARM A) in terms of overall survival (OS) in patients with unresectable LAD or mPDAC without disease progression following 3 months of induction mFOLFIRINOX triplet chemotherapy.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 340 people

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

Started

Mar 2025

Expected to finish

Jan 2030

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: * Patient able and willing to provide written informed consent and to comply with the study protocol. * Subjects must be ≥18 years. * Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic adenocarcinoma eligible for treatment in the first-line setting. * Presence of measurable or non-measurable disease assessed by CT scan and/or MRI according to RECIST 1.1. Note: any lesion which has been subjected to percutaneous therapies or radiotherapy should not be considered measurable, unless the lesion has clearly progressed since the procedure. * Availability of archival tumor sample (primary tumor or metastatic site) for biomarker analysis. * ECOG performance status of 0-1 (if age \< 70 years). If age ≥70 years, ECOG PS must be 0. * Estimated life expectancy \> 3 months. * Adequate baseline hematologic function characterized by the following at screening: * Absolute Neutrophil Count (ANC) ≥ 1.5 × 109/L. * Platelets count ≥ 100 × 109/L. * Hemoglobin ≥ 9 g/dl. Note: prior transfusions for patients with low hemoglobin are allowed. * Adequate liver function characterized by the following at screening: * Serum total bilirubin ≤ 1.5 × ULN and \< 2 mg/dL. Note: Subjects with Serum total bilirubin ≥ 1.5 × ULN and conjugated bilirubin ≤ ULN or \< 40% of total bilirubin are allowed. * Serum transaminases (AST and/or ALT) \< 3 x ULN (\< 5 x ULN in presence of liver metastasis). In participants with elevated AST or ALT, the values must be stable for at least 2 week and with no evidence of biliary obstruction by imaging. * Adequate renal function, i.e. serum creatinine ≤ 1.5 x institutional ULN and calculated by Cockroft-Gault formula or directly measured creatinine clearance ≥ 50 mL/min. * Adequate coagulation functions as defined by International Normalized Ratio (INR) ≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy). * No presence of complete dihydropyrimidine dehydrogenase (DPYD) enzyme deficiency (homozygous of the following DPYD polymorphisms: c1679GG, c1905+1AA, c2846TT) with DPYD gene testing mandatory at screening as per national guidelines. UDP-glucuronosyltransferase 1A1 (UGT1A1) testing is not mandatory. However, if UGT test is routinely performed in the participating centers, enrolment of patients carriers of variants of DPYD and homozygous variant UGT1A1 \[7/7\] has to be discussed with the Sponsor. * Women of childbearing potential must agree to remain abstinent (refrain from sexual intercourse) or use highly effective contraceptive methods, as defined in APPENDIX V of the full protocol, during the treatment period and for at least 7 months after the last administration of study treatments. * Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women \<1 year after the onset of menopause. * Men must agree to remain abstinent (refrain from sexual intercourse) or use highly effective contraceptive methods during the treatment period and for at least 7 months after the last administration of study treatments. * Participants must agree not to donate eggs/sperm for future use for the purposes of assisted reproduction during the study and for a period of 7 months after receiving the last dose of study treatment. Female and male participants should consider preservation of eggs/sperm prior to study treatment as anti-cancer treatments may impair fertility. Exclusion Criteria: * Pancreatic neuroendocrine, acinar, squamous/adenosquamous, or islet tumors. * Previous or concurrent systemic (e.g. cytotoxic or targeted or other experimental drugs) therapy for advanced pancreatic adenocarcinoma. Note: previous (neo)adjuvant or perioperative anti-cancer therapy for non-metastatic, resectable or borderline resectable PDAC, associated with surgery on the primary tumor, is allowed if \> 9 months have elapsed from the last dose of therapy and documented disease progression or relapse. * Major surgery or radiation therapy performed within \<4 weeks before randomization. Palliative radiotherapy to bone lesions is allowed if performed \> 2 weeks prior to start of study treatment. Patients must have recovered from an effect from major surgery. * Known allergy or hypersensitivity to study drugs and/or their excipients. * Unresolved toxicity ≥ CTCAE grade 2 attributed to any prior therapies (e.g. grade ≥2 peripheral neurotoxicity), excluding anemia or alopecia. * Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that requires directed therapy (such as radiotherapy or surgery) or increasing doses of corticosteroids 2 weeks prior to study entry. Participants with treated symptomatic brain metastases should be neurologically stable for 4 weeks post-treatment and prior to study entry. * Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years prior to study entry except for curatively treated basal cell carcinoma of the skin, in situ carcinoma of the cervix, and prostate cancer. * Know active uncontrolled hepatitis B or hepatitis C. Patients with a past or resolved HBV infection are eligible. Patients with chronic disease controlled by antiviral therapy or requiring prophylactic treatment are eligible. * Chronic or current active infectious disease requiring systemic antibiotics or antifungal treatment within 2 weeks prior to enrollment. * Known uncontrolled HIV infection. HIV-positive patients are eligible if their CD4+ cell count amounts to 300 cells per μL or more; HIV viral load must be undetectable per standard of care assay, and patients must be compliant with antiretroviral treatment. * Pregnant or breast-feeding patient, or patient planning to become pregnant within 7 months after the end of treatment. * Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA \> II, unstable angina pectoris, history of myocardial infarction within 3 months before study entry, significant arrhythmia). * Presence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent. * Any serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial.

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Conditions

The condition(s) this trial relates to.

Neoplasm Metastasis pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatic adenocarcinoma advanced or metastatic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 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

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • ASST Ospedale Maggiore di Crema

    RECRUITING

    Crema, 26013, Italy

  • Azienda Ospedaliero Universitaria Parma

    NOT_YET_RECRUITING

    Parma, 43126, Italy

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, 56126, Italy

  • Azienda Ospedaliero-Universitaria Maggiore Della Carità

    NOT_YET_RECRUITING

    Novara, 28100, Italy

  • Azienda Sanitaria Locale Della Provincia Di Biella

    RECRUITING

    Ponderano, 13875, Italy

  • Azienda Sanitaria Locale Napoli 1 Centro

    NOT_YET_RECRUITING

    Naples, 80147, Italy

  • Azienda Sanitaria Territoriale Di Pesaro E Urbino

    NOT_YET_RECRUITING

    Pesaro, 61122, Italy

  • Azienda Sanitaria Universitaria Friuli Centrale

    NOT_YET_RECRUITING

    Udine, 33100, Italy

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    NOT_YET_RECRUITING

    Brescia, 25123, Italy

  • Azienda Socio Sanitaria Territoriale Di Cremona

    NOT_YET_RECRUITING

    Cremona, 26100, Italy

  • Azienda USL Toscana Centro

    RECRUITING

    Prato, 59100, Italy

  • Azienda Unita Sanitaria Locale Della Romagna

    RECRUITING

    Ravenna, 48121, Italy

  • Careggi University Hospital

    NOT_YET_RECRUITING

    Florence, 50134, Italy

  • Centro Di Riferimento Oncologico Di Aviano

    RECRUITING

    Aviano, 33081, Italy

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    NOT_YET_RECRUITING

    Milan, 20122, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    NOT_YET_RECRUITING

    Milan, 20133, Italy

  • Fondazione IRCCS Policlinico San Matteo

    NOT_YET_RECRUITING

    Pavia, 27100, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    NOT_YET_RECRUITING

    Rome, 00168, Italy

  • Humanitas Istituto Clinico Catanese S.p.A.

    NOT_YET_RECRUITING

    Misterbianco, 95045, Italy

  • Humanitas Mirasole S.p.A.

    NOT_YET_RECRUITING

    Rozzano, 20089, Italy

  • I.F.O. Istituti Fisioterapici Ospitalieri

    NOT_YET_RECRUITING

    Rome, 00144, Italy

  • IRCCS Ospedale Policlinico San Martino

    NOT_YET_RECRUITING

    Genoa, 16132, Italy

  • Istituto Europeo Di Oncologia S.r.l.

    NOT_YET_RECRUITING

    Milan, 20141, Italy

  • Istituto Oncologico Veneto

    RECRUITING

    Padova, 35128, Italy

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

    RECRUITING

    Meldola, 47014, Italy

  • Pia Fondazione Di Culto E Religione Cardinale Giovanni Panico

    NOT_YET_RECRUITING

    Tricase, 73039, Italy

  • University Hospital Consorziale Policlinico

    NOT_YET_RECRUITING

    Bari, 70124, Italy

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