OncoMatch/Clinical Trials/NCT06897644
Gemcitabine Plus Nab-paclitaxel as Switch Maintenance Versus Continuation of Modified FOLFIRINOX as 1st Line Chemotherapy in Patients With Advanced Pancreatic Cancer.
Is NCT06897644 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for pancreatic adenocarcinoma advanced or metastatic.
Treatment: Oxaliplatin · Irinotecan (CPT-11) · Leucovorin · 5-FU (5-fluorouracil) · gemcitabine · Nab-paclitaxel — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Pancreatic Cancer
Biomarker criteria
Excluded: DPYD complete enzyme deficiency (homozygous c1679GG, c1905+1AA, c2846TT)
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.
Allowed: UGT1A1 homozygous variant UGT1A1 [7/7]
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.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: 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
Lab requirements
Blood counts
Absolute Neutrophil Count (ANC) ≥ 1.5 × 10^9/L. Platelets count ≥ 100 × 10^9/L. Hemoglobin ≥ 9 g/dl. Note: prior transfusions for patients with low hemoglobin are allowed.
Kidney function
serum creatinine ≤ 1.5 x institutional ULN and calculated by Cockroft-Gault formula or directly measured creatinine clearance ≥ 50 mL/min.
Liver function
Serum total bilirubin ≤ 1.5 × ULN and < 2 mg/dL; 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 baseline hematologic function... Adequate liver function... Adequate renal function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06897644 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Are patients with DPYD alterations eligible?
No. DPYD complete enzyme deficiency (homozygous c1679GG, c1905+1AA, c2846TT) is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages