NIFTY

NCT03524508 📎

Regimen

Experimental
Liposomal irinotecan (nal-IRI) 70 mg/m2 (free base equivalent) d1 + leucovorin 400 mg/m2 d1 + 5-FU 2400 mg/m2 46h infusion, q2w
Control
Leucovorin 400 mg/m2 + 5-FU 2400 mg/m2 q2w

Population

Metastatic BTC (unresectable/metastatic) previously treated with GemCis ± targeted therapy; ICC ~62%, ECC ~15%, GBC ~20%, ampullary ~3%; Korea multicenter; all Korean patients; ECOG PS 0-1

Key finding

NIFTY showed a highly significant PFS benefit (HR 0.56, p=0.002) for nal-IRI+5FU/LV vs 5FU/LV alone in previously treated BTC. The median PFS advantage of 5.7 months is the largest 2L PFS delta in any BTC RCT to date. However, OS was not the primary endpoint and the OS HR was 0.82 (95% CI 0.57-1.17, p=0.27) — not significant. The trial uses 5FU/LV alone as comparator, which is weaker than FOLFOX (ABC-06 standard), limiting direct comparison to current standard of care. Important distinction from NALIRICC: NIFTY is POSITIVE for PFS, NALIRICC is NEGATIVE for OS.

Source: PMID 36951834

Timeline

    Guideline citations

    • NCCN BTC (p.6)