PANORAMIX : Optimizing 1st-line NALIRIFOX and Exploring Microbiota's Role in 2nd Line Pancreatic Cancer Treatment
brief summary
The main objective of PANORAMIX phase II trial is to optimize first-lie (L1) NALIRIFOX treatment for pancreatic cancer through the implementation of 5-fluorouracil (5-FU) maintenance therapy. Additionally, it aims to investigate the role of antibiotics and microbiota in second-line (L2) treatment.
detailed description
This randomized non-comparative phase II study consists of two sequential steps.
Step 1 (main objective), the primary goal is to assess the efficacy of a maintenance strategy with LV5FU2 alone after disease control with first-line NALIRIFOX-based chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
Step 2 of the study (exploratory objective), aim is to assess the efficacy and safety of the addition of fluoroquinolone (ciprofloxacin) to gemcitabine-based chemotherapy in second-line setting.
official title
Pancreatic Cancer First-line NALIRIFOX Optimization With 5-FU Maintenance and Role of Antibiotics and Microbiota Exploration in Second-line Treatment - A Non-comparative, Randomized Phase II PANORAMIX GERCOR G-116 PRODIGE 105 Study.