Table 4.
Clinical trials of adjuvant treatment in hilar cholangiocarcinoma
|
Study
|
Design
|
Sample size
|
Treatment
|
Control
|
Key findings
|
| JCOG1202, ASCOT | Phase 3 | Total: 440; CCA: 180 | S-11 | Observation | 3-yr OS: 77.1% vs 67.6% (95%CI: 61.0%-73.3%); 3-yr RFS: 62.4% vs 50.9% (95%CI: 44.1%-57.2%) |
| BILCAP | Phase 3 | Total: 447; CCA: 284 | Capecitabine, duration: 6 months | Observation | OS (month): 51.1 vs 36.4 (95%CI: 34.6%-59.1%); RFS (month): 24.4 vs 17.5 (95%CI: 18.6%-35.9%) |
| SWOG S0809 | Phase 2 | Total: 79; CCA: 53 | gemcitabine and capecitabine followed by CRRT | None | Median OS: 35 months (R0, 34 months, R1, 35 months) |
1
S-1 is available only in Japan.
95%CI: 95% Confidence interval; CCA: Cholangiocarcinoma; CRRT: Concomitant chemoradiation therapy; OS: Overall survival; RFS: Recurrence-free survival.