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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

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

Gemcitabine Plus Nab-paclitaxel as Switch Maintenance Versus Continuation of Modified FOLFIRINOX as 1st Line Chemotherapy in Patients With Advanced Pancreatic Cancer. (NCT06897644) is a Phase 3 interventional studying Pancreatic Adenocarcinoma Advanced or Metastatic, sponsored by Gruppo Oncologico del Nord-Ovest. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Pancreatic Adenocarcinoma Advanced or Metastatic, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 340 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - Patient able and willing to provide written willing to sign a consent form and to comply with the study protocol. - Subjects must be ≥18 years. - diagnosed by tissue sample (biopsy-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. - You should be able to carry out daily activities with 0 level of ability (ECOG 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. - blood count (hemoglobin) at least 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 kidney function (creatinine clearance) at least 50 mL/min. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Oxaliplatin

85 mg/sqm iv over 2 hours day 1

DRUG

Irinotecan (CPT-11)

150 mg/sqm iv over 60 minutes day 1

DRUG

Leucovorin

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

DRUG

5-FU (5-fluorouracil)

2400 mg/sqm 46-hours infusion

DRUG

gemcitabine

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

DRUG

Nab-paclitaxel

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

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Centro Di Riferimento Oncologico Di Aviano
Aviano, Italy, Italy
University Hospital Consorziale Policlinico
Bari, Italy, Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, Italy, Italy
ASST Ospedale Maggiore di Crema
Crema, Italy, Italy
Azienda Socio Sanitaria Territoriale Di Cremona
Cremona, Italy, Italy
Careggi University Hospital
Florence, Italy, Italy
IRCCS Ospedale Policlinico San Martino
Genoa, Italy, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Meldola, Italy, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, Italy
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, Italy
Humanitas Istituto Clinico Catanese S.p.A.
Misterbianco, Italy, Italy
Azienda Sanitaria Locale Napoli 1 Centro
Naples, Italy, Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carità
Novara, Italy, Italy
Istituto Oncologico Veneto
Padova, Italy, Italy
Azienda Ospedaliero Universitaria Parma
Parma, Italy, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, Italy
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Pesaro, Italy, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, Italy

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06897644), the sponsor (Gruppo Oncologico del Nord-Ovest), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06897644 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06897644?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06897644?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06897644. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06897644. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.