Phase 2 Study Comparing Sequential Gembrax Followed by Folfirinox Versus Folfirinox Alone for First-Line Treatment of Metastatic Pancreatic Cancer

What this Trial Is About

Researchers are evaluating a new treatment approach for patients with metastatic pancreatic cancer, comparing a sequential therapy called Gabrinox Gembrax regimen followed by Folfirinox to the standard Folfirinox alone. Pancreatic cancer has a poor prognosis with limited treatment options, and this study aims to improve outcomes by potentially increasing response rates and survival while reducing toxicities. The study involves two treatment groups. Patients in the experimental group receive up to 6 cycles over 12 months, each cycle including three administrations of Gembrax albumin-bound paclitaxel and gemcitabine followed by two administrations of Folfirinox oxaliplatin, irinotecan, folinic acid, and 5-fluorouracil. The comparison group receives up to 3 cycles over 6 months of Folfirinox only, with four administrations per cycle. Treatments are given in scheduled doses with rest periods in between. Participants will undergo regular evaluations including scans to measure tumor response, blood tests to monitor health and side effects, and quality of life questionnaires at multiple time points up to two years. Researchers will track progression-free survival, treatment tolerability, overall survival, and tumor DNA markers. Follow-up includes monitoring for up to two years to assess long-term outcomes and safety.

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients