SWOG-1815

NCT03768414 📎

Regimen

Experimental
Gemcitabine 800 mg/m2 d1, d8 + cisplatin 25 mg/m2 d1, d8 + nab-paclitaxel 100 mg/m2 d1, d8 q3w (triplet)
Control
Gemcitabine 1000 mg/m2 d1, d8 + cisplatin 25 mg/m2 d1, d8 q3w (GemCis doublet)

Population

Advanced BTC (unresectable/metastatic), 1L treatment-naive; ICC ~55%, ECC ~15%, GBC ~28%, ampullary ~2%; US multicenter (SWOG intergroup); mixed GBC/CCA enrollment reflecting North American epidemiology

Key finding

SWOG S1815 definitively failed to show OS benefit from adding nab-paclitaxel to GemCis in advanced BTC. The HR of 0.93 crossed the null with a p of 0.52. Subgroup analyses showed no enriched population benefiting from the triplet. The trial is an important negative result because nab-paclitaxel + GemCis had shown activity in phase 2 (Shroff 2019) and enthusiasm was high. The failure highlights the difficulty of improving on GemCis with cytotoxic agents alone in an unselected BTC population, and reinforces the field's shift toward IO-based combinations. SWOG-1815 was originally designed pre-IO era; by the time it completed, IO+GemCis had already become standard.

Source: PMID 39671534

Timeline

    Guideline citations

    • NCCN BTC (p.6)