Current insights and future perspectives of treatment strategies for biliary tract cancer

Table 2 Adjuvant chemotherapy trials for biliary tract cancer

Trial	Regimen	Country/no. of sites	Sample size	Primary endpoint	Enrollment period	Results	Ref.
BILCAP	Capecitabine	United Kingdom/44	447	OS	2006-2014	No OS difference in ITT (HR = 0.81, P = 0.097); sensitivity and PPS analysis suggested that capecitabine can improve OS (HR = 0.71, P = 0.01)	[35]
BCAT	GEM	Japan/33	225	OS	2007-2011	No OS or RFS difference (HR = 1.01, P = 0.964)	[32]
PRODIGE 12-ACCORD 18	GEMOX	France/33	196	RFS	2009-2014	No RFS benefit (HR = 0.88, P = 0.48)	[38]
JCOG1202 (ASCOT)	S-1	Japan/38	440	OS	2013-2018	OS benefit (HR = 0.69, P = 0.008); RFS not significant	[37]
ACTICCA-1	GEM + CDDP vs capecitabine	Germany, United Kingdom, Netherlands, Austria, Denmark/90+	594	DFS	2014-2022	Follow-up ongoing1	[39]

¹The original trial was designed to verify the efficacy of the initial surgery alone. Following the results of the BILCAP trial, the trial was modified to verify the superiority of gemcitabine + cisplatin therapy over capecitabine therapy (ACTICCA-1 Protocol V7.0, University of Birmingham, 2022).

GEM: Gemcitabine; GEMOX: Gemcitabine + oxaliplatin; CDDP: Cisplatin; OS: Overall survival; RFS: Recurrence-free survival; DFS: Disease-free survival; HR: Hazard ratio; ITT: Intention-to-treat; PPS: Per protocol set.