Pancreatic ductal adenocarcinoma (PDAC) · line 1 · NALIRIFOX
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Line of therapy | 1 |
|---|---|
| Track | standard |
| Linked regimen | REG-NALIRIFOX |
| ID | IND-PDAC-METASTATIC-1L-NALIRIFOX |
|---|---|
| Type | Indication |
| Status | reviewed 2026-05-08 | pending_clinical_signoff |
| Diseases | DIS-PDAC |
| Sources | SRC-ESMO-PANCREATIC-2024 SRC-NAPOLI-3-WAINBERG-2024 SRC-NCCN-PANCREATIC-2025 |
Notes
NAPOLI-3 (PMID 37708904) is the landmark RCT establishing NALIRIFOX as Category 1 1L option for fit ECOG 0-1 mPDAC. FDA approval for liposomal irinotecan in 1L mPDAC: 2024 (label expansion from prior 2015 2L approval). ONIVYDE not registered in Ukraine — significant access barrier. Sister 1L indications: IND-PDAC-METASTATIC-1L-FOLFIRINOX (preferred Ukraine default with full NSZU access) and IND-PDAC-METASTATIC-1L-GEM-NAB-PAC (frailty-friendly alternative). Algorithm partner: ALGO-PDAC-METASTATIC-1L (pending update to add NALIRIFOX as Category 1 alongside FOLFIRINOX/gem-nab-pac). Clinical exclusions captured at the regimen-level dose_adjustments (REG-NALIRIFOX) rather than as hard_contraindications IDs since the Contraindication-entity scaffold for these conditions (bilirubin >2× ULN, ECOG ≥2, severe myelosuppression, pre-existing Grade ≥2 peripheral neuropathy, active IBD/severe diarrhea) is not yet authored. Pending Contraindication entities can be added in a follow-up chunk when the contraindication taxonomy is filled in. UGT1A1 genotyping desired pre-treatment but TEST-UGT1A1-GENOTYPE entity is not yet authored; see drug-level pharmacology notes.
Used By
Algorithms
ALGO-PDAC-METASTATIC-1L- ALGO-PDAC-METASTATIC-1L