OncoMatch/Clinical Trials/NCT04570943

Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

Is NCT04570943 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Gabrinox for locally advanced pancreatic adenocarcinoma.

Phase 2RecruitingInstitut du Cancer de Montpellier - Val d'AurelleNCT04570943Data as of May 2026

Treatment: Gabrinox — The aim of this study is to demonstrate the efficacy of intensified and sequential chemotherapy (Gabrinox) comprising Gembrax regimen (Gemcitabine-Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) in patients with locally advanced pancreatic adenocarcinoma. The study will also demonstrate the feasibility of combining this intensified chemotherapy with MRI-guided stereotactic radiotherapy in non-progressive patients after the chemotherapy by Gabrinox regimen.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Biomarker criteria

Excluded: UGT1A1 *28

homozygous Uridine DiPhosphate Glucuronosyl Transferase 1 A1 (UGT1A1 * 28)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: chemotherapy

Any previous treatment for pancreatic cancer (e.g. chemotherapy, radiotherapy, surgery, targeted therapy, experimental therapy)

Cannot have received: radiotherapy

Any previous treatment for pancreatic cancer (e.g. chemotherapy, radiotherapy, surgery, targeted therapy, experimental therapy)

Cannot have received: surgery

Any previous treatment for pancreatic cancer (e.g. chemotherapy, radiotherapy, surgery, targeted therapy, experimental therapy)

Cannot have received: targeted therapy

Any previous treatment for pancreatic cancer (e.g. chemotherapy, radiotherapy, surgery, targeted therapy, experimental therapy)

Cannot have received: experimental therapy

Any previous treatment for pancreatic cancer (e.g. chemotherapy, radiotherapy, surgery, targeted therapy, experimental therapy)

Cannot have received: radiotherapy

Prior radiotherapy likely to overlap with the planned study radiotherapy area (e.g. previous abdominal irradiation).

Lab requirements

Blood counts

Neutrophils ≥ 2 000/mm3; Platelets ≥ 100 000/mm3; Hemoglobin ≥ 9 g/dl

Kidney function

Creatininaemia within reference limits, or calculated clearance ≥50 ml/min (CKDEPI formula)

Liver function

AST and ALT ≤ 2.5 x ULN; total bilirubin ≤ 1.5 x ULN (special conditions for patients with metallic biliary prosthesis)

Hematological assessment within 14 days before inclusion, defined by: Neutrophils ≥ 2 000/mm3; Platelets ≥ 100 000/mm3; Hemoglobin ≥ 9 g/dl. Liver function (within 14 days before inclusion) defined by: AST and ALT ≤ 2.5 x ULN; total bilirubin ≤ 1.5 x ULN. Creatininaemia within the reference limits, or calculated clearance ≥50 ml/min for patients with a serum creatinine value above or below the reference values (CKDEPI formula).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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