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 (Jun 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
Treatments studied
Other
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
Demographics
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.
Frequently asked questions
Is NCT05065801 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 UGT1A1 alterations eligible?
No. UGT1A1 *28 homozygous is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 75 years or younger.
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