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Comparing two chemotherapy approaches for 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

Phase 3 Interventional Gruppo Oncologico del Nord-Ovest · NCT06897644

This study is testing whether switching to a different chemotherapy combination or continuing the current treatment helps people with advanced pancreatic cancer live longer and feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment340 (estimated)
Ages18 Years and up
SexAll
SponsorGruppo Oncologico del Nord-Ovest Academic / other
Drugs / interventionsradiation, chemotherapy
Locations28 sites (Aviano, Italy and 27 other locations)
Trial IDNCT06897644 on ClinicalTrials.gov

What this trial studies

This phase III trial, known as PANThEON, evaluates the effectiveness of switch maintenance therapy using gemcitabine plus nab-paclitaxel against the continuation of modified FOLFIRINOX in patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma. Patients who have not experienced disease progression after three months of initial mFOLFIRINOX treatment will be randomized into one of the two treatment arms. The study aims to determine which approach leads to better overall survival outcomes. Radiological assessments will be conducted to evaluate tumor response before and after the induction chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable locally advanced or metastatic pancreatic adenocarcinoma who have not progressed after initial chemotherapy.

Not a fit: Patients with resectable pancreatic cancer or those who have progressed after initial chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option that improves survival rates for patients with advanced pancreatic cancer.

How similar studies have performed: Other studies have shown promising results with similar chemotherapy regimens, suggesting that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Aviano, Italy and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pancreatic Adenocarcinoma Advanced or Metastaticfirst linemFOLFIRINOXchemotherapypancreasGemcitabine with Nab-Paclitaxelswitch maintenancepancreatic cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.