OncoMatch/Clinical Trials/NCT05065801
Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients
Is NCT05065801 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including GEMBRAX/FOLFIRINOX Arm A and FOLFIRINOX Arm B for metastatic pancreatic cancer.
Treatment: GEMBRAX/FOLFIRINOX Arm A · FOLFIRINOX Arm B — The aim of this study is to evaluate the efficacy of sequential treatment (Gabrinox) comprising Gembrax regimen (Gemcitabine -Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) compared to folfirinox alone in patients treated in first metastatic line pancreatic cancer
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Biomarker criteria
Excluded: UGT1A1 *28 homozygous
homozygous for know UGT1A1 * 28
Disease stage
Required: Stage IV
Metastatic disease required
One or more metastatic lesion (s) measurable (Recist 1.1)
Performance status
WHO 0–1
Prior therapy
Cannot have received: radiotherapy
Previous treatment with radiotherapy ... for the treatment of metastatic disease
Cannot have received: surgery
Previous treatment with ... surgery ... for the treatment of metastatic disease
Cannot have received: chemotherapy
Previous treatment with ... chemotherapy ... for the treatment of metastatic disease
Cannot have received: experimental therapy
Previous treatment with ... experimental therapy for the treatment of metastatic disease
Lab requirements
Blood counts
Neutrophils ≥ 2 × 10^9 / L; Platelets ≥ 100,000 / mm3 (100 × 10^9 / L); Hemoglobin ≥ 9 g / dl
Kidney function
Serum creatinine within the norm limits or calculated clearance ≥ 50ml / min for patients with a serum creatinine value above or below the norm values (clearance calculated by the CKD-EPI formula)
Liver function
AST and ALT ≤ 2.5 x ULN, unless liver metastases are present in this case AST and ALT ≤ 5 × ULN is allowed; Total bilirubin ≤ 1.5 x ULN
Cardiac function
ECG with a QTc interval ≤ 450 ms for men and ≤ 470 ms for women
Acceptable hematological assessment ... Acceptable renal and hepatic function ... ECG with a QTc interval greater than 450 ms for men and greater than 470 ms for women
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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