BILCAP
After macroscopically complete resection of biliary tract cancer, does adjuvant capecitabine improve survival compared with observation?
Trial design and population
Key results
Long-term ITT median OS 49.6 months with capecitabine vs 36.1 months with observation (adjusted HR 0.84; 95% CI 0.67–1.06). Prespecified sensitivity analysis adjusted for minimization factors, nodal status, grade and sex: HR 0.74 (95% CI 0.59–0.94). The primary ITT analysis did not reach conventional statistical significance.
Source-reported outcome visualization
Median overall survival · Median, months
Bars display source-reported values for the named endpoint; where the endpoint is a median, bars compare medians and do not represent probabilities. No unreported rates are inferred.
Absolute Effect
Median OS difference 13.5 months; this is not a fixed-time absolute risk difference.
NNT: Not quantifiable from median OS difference. No NNT is derived from median survival/PFS differences.
NNH / harm: Among capecitabine-treated patients, 44% had at least one grade 3 toxicity; common grade 3 toxicities included hand-foot syndrome (20%), diarrhoea (8%) and fatigue (8%).
NNT/NNH are only displayed where the endpoint and time horizon support a defensible absolute-risk calculation. Otherwise, the source-reported outcome is visualized.
Safety and treatment burden
Among capecitabine-treated patients, 44% had at least one grade 3 toxicity; common grade 3 toxicities included hand-foot syndrome (20%), diarrhoea (8%) and fatigue (8%).
Follow-up, maturity and limitations
Interpret the negative primary ITT analysis alongside prespecified sensitivity/per-protocol analyses and long-term follow-up. Toxicity rates were collected asymmetrically in the original study.
Clinical interpretation
Current-practice context · reviewed 20 October 2026
This page separates original trial findings from contemporary treatment context. Confirm current disease-specific guidelines, local regulatory status, biomarker requirements, prior treatment exposure and patient-specific contraindications before applying the evidence. Historical comparators may no longer represent current standard practice; subgroup findings and immature endpoints should not be generalized.