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Anakinra + fluorouracil + irinotecan + oxaliplatin is an investigational combination therapy being evaluated by the Baylor Research Institute for the treatment of metastatic pancreatic ductal adenocarcinoma (PDAC). This regimen combines the interleukin-1 (IL-1) receptor antagonist anakinra (marketed as Kineret) with a modified FOLFIRINOX chemotherapy backbone (consisting of fluorouracil, irinotecan, and oxaliplatin). The therapeutic rationale is based on evidence that IL-1 is a key driver of the inflammatory cascade and the dense fibroinflammatory stroma characteristic of pancreatic cancer, which often confers resistance to standard therapies. By inhibiting both IL-1 alpha and IL-1 beta through the IL-1 receptor, anakinra aims to modulate the tumor microenvironment and enhance the efficacy of the cytotoxic chemotherapy components. A Phase 1 pilot study (NCT02021422) demonstrated that the combination is safe and feasible in patients with metastatic disease.
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