ABC-06

NCT01926236 📎

Regimen

Experimental
Active symptom control (ASC) + modified FOLFOX: oxaliplatin 85 mg/m2 d1 + leucovorin 350 mg d1 + 5-FU 400 mg/m2 bolus d1 + 5-FU 2400 mg/m2 46h infusion, q2w × up to 12 cycles
Control
Active symptom control (ASC) alone

Population

Advanced BTC (unresectable/metastatic) previously treated with GemCis (progressed after 1L); ICC ~57%, ECC ~17%, GBC ~20%, ampullary ~6%; UK multicenter; ECOG PS 0-1

Key finding

ABC-06 established modified FOLFOX as the first evidence-based 2L standard for advanced BTC after GemCis failure, showing a statistically significant but modest OS benefit (0.9 months median, HR 0.69). The 12-month OS landmark difference (26% vs 11%) is more clinically impactful than the median. The trial is notable for its comparator (ASC alone), which is ethically appropriate given the absence of proven 2L therapy at trial initiation. Toxicity was manageable; FOLFOX is well-tolerated relative to triplet regimens. ABC-06 is now the reference comparator for all subsequent 2L BTC trials.

Source: PMID 33798493

Timeline

    Guideline citations

    • NCCN BTC (p.39)