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Pancreatic Adenocarcinoma Advanced or MetastaticPhase 3PANThEONNCT06897644

Gemcitabine Plus Nab-paclitaxel as Switch Maintenance Versus Continuation of Modified FOLFIRINOX as 1st Line Chemotherapy in Patients With Advanced Pancreatic Cancer.

A Phase 3 study testing Oxaliplatin, Irinotecan (CPT-11) and Leucovorin in people with Pancreatic Adenocarcinoma Advanced or Metastatic, run by Gruppo Oncologico del Nord-Ovest at 28 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oxaliplatin, Irinotecan (CPT-11) and Leucovorin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
28 sitesItaly
Study dates
27 Mar 2025to 1 Jan 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

28 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Monica Niger, MD contact

+3902 2390 2919

monica.niger@istitutotumori.mi.it

28 sites in 1 country

Italy28 sites, 28 recruiting

  • Centro Di Riferimento Oncologico Di Aviano

    Aviano, 33081

    Elena Ongaro, +390434659050, elena.ongaro@cro.it

    Recruiting

  • University Hospital Consorziale Policlinico

    Bari, 70124

    Francesco Mannavola, +390805592780, francesco.mannavola@policlinico.ba.it

    Not yet recruiting

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123

    Giuseppina Arcangeli, +390303995260, gy_arca@tiscali.it

    Not yet recruiting

  • ASST Ospedale Maggiore di Crema

    Crema, 26013

    Gianluca Tomasello, +390373280400, gianluca.tomasello@asst-crema.it

    Recruiting

  • Azienda Socio Sanitaria Territoriale Di Cremona

    Cremona, 26100

    Maria Bonomi, +390372405246, maria.bonomi@asst-cremona.it

    Not yet recruiting

  • Careggi University Hospital

    Florence, 50134

    Lorenzo Antonuzzo, +390557949648, lorenzo.antonuzzo@unifi.it

    Not yet recruiting

  • IRCCS Ospedale Policlinico San Martino

    Genoa, 16132

    Roberto Murialdo, +390103538667, rozzis752000@yahoo.it

    Not yet recruiting

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

    Meldola, 47014

    Ilario Giovanni Rapposelli, +390543739100, ilario.rapposelli@irst.emr.it

    Recruiting

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

    Barbara Galassi, +390255032666, barbara.galassi@policlinico.mi.it

    Not yet recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Monica Niger, +3902 2390 2919, monica.niger@istitutotumori.mi.it

    Federica Palermo, +3902 2390 3835, federica.palermo@istitutotumori.mi.it

    Not yet recruiting

  • Istituto Europeo Di Oncologia S.r.l.

    Milan, 20141

    Chiara Alessandra Cella, +390257489258, chiaraalessandra.cella@ieo.it

    Not yet recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

    Katia Bruna Bencardino, +390264442291, katia.bencardino@ospedaleniguarda.it

    Recruiting

  • Humanitas Istituto Clinico Catanese S.p.A.

    Misterbianco, 95045

    Carlo Carnaghi, +3909573390900, carlo.carnaghi@humanitascatania.it

    Not yet recruiting

  • Azienda Sanitaria Locale Napoli 1 Centro

    Naples, 80147

    Laura Attademo, +3908118775339, oncologia.odm@aslnapoli1centro.it

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria Maggiore Della Carità

    Novara, 28100

    Laura Giovanna Forti, +3903213732148, laura.forti@maggioreosp.novara.it

    Not yet recruiting

  • Istituto Oncologico Veneto

    Padova, 35128

    Francesca Bergamo, +390498215953, francesca.bergamo@iov.veneto.it

    Recruiting

  • Azienda Ospedaliero Universitaria Parma

    Parma, 43126

    Ingrid Garajovà, +390521702660, igarajova@ao.pr.it

    Not yet recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Salvatore Corallo, +390382501671, s.corallo@smatteo.pv.it

    Not yet recruiting

  • Azienda Sanitaria Territoriale Di Pesaro E Urbino

    Pesaro, 61122

    Rita Chiari, +393316893387, rita.chiari@sanita.marche.it

    Not yet recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

    Caterina Vivaldi, +39050992466, caterinavivaldi@gmail.com

    Recruiting

  • Azienda Sanitaria Locale Della Provincia Di Biella

    Ponderano, 13875

    Francesco Leone, +3901515157503, francesco.leone@aslbi.piemonte.it

    Recruiting

  • Azienda USL Toscana Centro

    Prato, 59100

    Samantha Di Donato, +390574802525, samantha.didonato@uslcentro.toscana.it

    Recruiting

  • Azienda Unita Sanitaria Locale Della Romagna

    Ravenna, 48121

    Stefano Tamberi, +390544285206, stefano.tamberi@auslromagna.it

    Recruiting

  • I.F.O. Istituti Fisioterapici Ospitalieri

    Rome, 00144

    Emanuela Dell'Aquila, +390652666762, emanuela.dellaquila@ifo.it

    Not yet recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168

    Lisa Salvatore, +390630156318, lisa.salvatore@policlinicogemelli.it

    Not yet recruiting

  • Humanitas Mirasole S.p.A.

    Rozzano, 20089

    Silvia Bozzarelli, +390282247255, silvia.bozzarelli@cancercenter.humanitas.it

    Not yet recruiting

  • Pia Fondazione Di Culto E Religione Cardinale Giovanni Panico

    Tricase, 73039

    Emiliano Tamburini, +390833773111, e.tamburini@piafondazionepanico.it

    Not yet recruiting

  • Azienda Sanitaria Universitaria Friuli Centrale

    Udine, 33100

    Silvio Ken Garattini, +390432554586, silvioken.garattini@asufc.sanita.fvg.it

    Not yet recruiting

Other trials in Italy

About this study

Official title: 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

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.

Read the detailed description

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

The induction chemotherapy regimen will be mFOLFIRINOX as per standard of care. Treatment must be continued for up to a maximum of 14 weeks, corresponding to ~ 6 bi-weekly cycles. A minimum of 4 treatment cycles administered is necessary for the patient to be evaluable for randomization.

Radiological tumor assessment will be performed before the start and after completion of induction chemotherapy. Patients with complete/partial response or stable disease (CR/PR/SD) or without evidence of progressive disease (PD) in case of non-measurable disease will be randomized in a 1:1 ratio.

Stratification factors will be ECOG Performance status (PS, 0 vs 1) and disease extension (LAD vs metastatic with presence of liver metastases vs metastatic without presence of liver metastases).

Being tested
Oxaliplatin, Irinotecan (CPT-11), Leucovorin, 5-FU (5-fluorouracil), gemcitabine
Keywords
first line, mFOLFIRINOX, chemotherapy, pancreas, Gemcitabine with Nab-Paclitaxel, switch maintenance, pancreatic cancer
Medical subject headings
Neoplasm Metastasis, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxaliplatinDrug

    85 mg/sqm iv over 2 hours day 1

  • Irinotecan (CPT-11)Drug

    150 mg/sqm iv over 60 minutes day 1

  • LeucovorinDrug

    Leucovorin 400 mg/sqm (racemic) or l-Leucovorin 200 mg/sqm over 2 hours day 1

  • 5-FU (5-fluorouracil)Drug

    2400 mg/sqm 46-hours infusion

  • gemcitabineDrug

    1000 mg/sqm over 30 minutes on Days 1,8,15 of a 28-day cycles

  • Nab-paclitaxelDrug

    125 mg/sqm over 30 minutes on Days 1,8,15 of a 28-day cycles

Study groups in NCT06897644
Study groupRoleWhat they receive
ARM A - continuation of mFOLFIRINOXActive comparatorPatients in Arm A will receive continuation of the same regimen used as induction chemotherapy: * Oxaliplatin 85 mg/sqm; * Irinotecan 150 mg/sqm; * Leucovorin 400 mg/sqm (racemic) or l-Leucovorin 200 mg/sqm; * 5-FU 2400 mg/sqm 46-hours infusion; every 2 weeks. Treatment will continue until PD, unacceptable toxicity, informed consent withdrawal, or patient's death. In case of permanent discontinuation of one or more compounds due to unacceptable toxicity, treatment with the other agent(s) may be continued until PD.
Receives: Drug: Oxaliplatin; Drug: Irinotecan (CPT-11); Drug: Leucovorin; Drug: 5-FU (5-fluorouracil)
ARM B - switch maintenance with Gem-NabPExperimentalPatients in Arm B will receive: * Gemcitabine 1000 mg/sqm on Days 1,8,15 of every 28-day cycles; * Nab-Paclitaxel 125 mg/sqm on Days 1,8,15 of every 28-day cycles. Treatment will continue until PD, unacceptable toxicity, informed consent withdrawal, or patient's death. In case of permanent discontinuation of one compound due to unacceptable toxicity, treatment with the other agent may be continued until PD in each arm.
Receives: Drug: gemcitabine; Drug: Nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS is defined as the time from randomization to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.

    Measured: from date of randomization to date of death (or last follow up for alive patients), assessed up to 48 months

Secondary outcomes (8)

  1. Progression Free Survival (PFS)

    PFS will be defined as the time from randomization until disease progression or death, whichever will occur first; for patients alive and without progression time will be censored at the last known follow-up.

    Measured: from randomization to disease progression or death from any cause, assessed up to 48 months

  2. Time to Treatment Failure (TTF)

    TTF will be defined as the time from randomization to discontinuation of treatment for any reason, including progressive disease, treatment toxicity and death; in the absence of treatment failure time will be censored at the last known follow-up.

    Measured: from randomization to discontinuation of treatment for any reason, including progressive disease, treatment toxicity and death, assessed up to 48 months

  3. Objective Response Rate (ORR)

    ORR is defined as the percentage of patients achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria

    Measured: up to 48 months

  4. Disease Control Rate (DCR)

    DCR is defined as the percentage of patients achieving a complete (CR) or partial (PR) response or a stable disease (SD), according to RECIST 1.1 criteria

    Measured: Up to approximately 48 months

  5. Quality of life (QoL)

    QoL will be estimated with EORTC QLQ-C30 and the modules PAN26, FA12, CAX24, COMU26 a will be performed with the EORTC QLQ INFO25, which is a valid self-reported instrument consisting of 25 questions. Communication between patients and professionals will be assessed with the EORT QLC COMU26.

    Measured: Up to approximately 48 months

  6. Toxicity rate

    Toxicity is defined as the percentage of patients experiencing a specific adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0).

    Measured: Up to approximately 48 months

  7. Proportion of patients not eligible to randomization

    Proportion of patients not eligible to randomization is defined as patients who started induction treatment but result not eligible due to i) clinical deterioration or treatment toxicity, ii) withdraw consent or iii) disease progression documented as best response, iv) other causes

    Measured: Up to approximately 48 months

  8. Subsequent treatment line frequency

    Subsequent treatment line frequency is defined as the percentage of patients who undergo a systemic treatment (excluding locoregional treatments or surgical treatment of unresectable disease) after progression to first line in both arms

    Measured: Up to approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2025
  2. Study start27 Mar 2025
  3. Primary completion1 Jan 2029 (estimated)
  4. Study completion1 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06897644
Sponsor's protocol ID
PANThEON
Other IDs
2024-515214-41-00
Acronym
PANThEON
Status last verified
Sep 2026
First submitted
20 Mar 2025
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sciortino C, Nichetti F, Bergamo F, Palermo F, Tamberi S, Vivaldi C, Ongaro E, Arcangeli G, Marchesi S, Giommoni E, Cella CA, Pircher C, Chiaramonte A, Bencardino K, Sottotetti E, Martinetti A, Rapposelli IG, Corallo S, Di Donato S, Murialdo R, Delliponti L, Salvatore L, Bozzarelli S, Dell'Aquila E, Miceli R, Carnaghi C, Tomasello G, Rivizzigno P, Bonomi M, Mannavola F, Forti L, Garajova I, Attademo L, Galassi B, Chiari R, Leone F, Garattini SK, Tamburini E, Pietrantonio F, Niger M. A phase III randomized clinical trial of Gemcitabine and Nab-Paclitaxel as switch maintenance versus continuation of modified FOLFIRINOX as first-line chemotherapy in patients with advanced pancreatic cancer: The PANThEON Study. Dig Liver Dis. 2025 Dec;57(12):2470-2477. doi: 10.1016/j.dld.2025.11.007. Epub 2025 Nov 28.

    PubMed 41318310

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oxaliplatin, Irinotecan (CPT-11) and Leucovorin in people with Pancreatic Adenocarcinoma Advanced or Metastatic, run by Gruppo Oncologico del Nord-Ovest at 28 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Monica Niger, MD (+3902 2390 2919, monica.niger@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: from date of randomization to date of death (or last follow up for alive patients), assessed up to 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06897644, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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