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 (May 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
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.
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