BILCAP

NCT00363584 📎

Regimen

Experimental
Capecitabine 1250 mg/m2 twice daily days 1-14 q3w × 8 cycles (24 weeks total)
Control
Observation

Population

Resected biliary tract cancer (intrahepatic and extrahepatic cholangiocarcinoma + gallbladder cancer), R0 or R1 resection, mixed subtype but predominantly intrahepatic/extrahepatic cholangiocarcinoma (~65%) and GBC (~30%), UK multicenter

Key finding

BILCAP narrowly missed its ITT primary OS endpoint (p=0.097), but the pre-specified per-protocol analysis showed a significant 25% reduction in death risk with capecitabine. The ITT/per-protocol discordance reflects protocol deviations (dose reductions, early stops) in a real-world chemotherapy-tolerability context. Most major guidelines (ESMO, NCCN, CSCO) adopted capecitabine adjuvant therapy as standard of care based on the per-protocol result and absence of better data, making BILCAP the most practice-changing adjuvant BTC trial until ASCOT. The trial enrolled all BTC subtypes, precluding subtype-specific conclusions.

Source: PMID 30922733

Timeline

    Guideline citations

    • NCCN BTC (p.12)