ACTICCA-1
Regimen
- Experimental
- Gemcitabine 1000 mg/m2 d1, d8 + cisplatin 25 mg/m2 d1, d8 q3w × 8 cycles (24 weeks)
- Control
- Observation (original protocol); amended to capecitabine 1250 mg/m2 bid d1-14 q3w after BILCAP publication
Population
Resected biliary tract cancer (ICC, ECC, GBC) and muscle-invasive gallbladder carcinoma, R0 or R1 resection, European multicenter (Germany-led); target accrual 781 patients in original protocol; subsequently amended to ~783 with control arm changed to capecitabine after BILCAP
Key finding
ACTICCA-1 is the ongoing landmark adjuvant trial testing GemCis doublet (the same backbone that proved superior in advanced BTC via ABC-02) in the resectable setting. The control arm was pragmatically amended from observation to capecitabine after BILCAP's per-protocol positive result, making it the first adjuvant trial to directly test whether GemCis outperforms capecitabine mono. Results are awaited with high interest; if GemCis fails to beat capecitabine, it would suggest the advanced-disease doublet advantage does not translate to the adjuvant setting. Primary publication pending.
Source: PMID 26228433