Contemporary Tailored Oncology Treatment of Biliary Tract Cancers

Table 2

On-going clinical trials investigating adjuvant therapies following resection of biliary tract cancers.

Agent [trial]	Mechanism of action	Population	Phase	Treatment arms	Planned recruitment	Primary endpoint	Clinical trial identifier
GEM/CIS [ACTICCA-1]	Cytotoxic	Resected localised biliary tract cancer, following complete macroscopic resection	III; Open-label	vs. (1 : 1)	Recruiting; Target	DFS	NCT02170090
GEM/CAP [AdBTC-1]	Cytotoxic	Resected localised biliary tract cancer, following complete macroscopic resection	III; Open-label	vs.	Recruiting; Target	DFS	NCT03779035
S-1 [JCOG1202, ASCOT]	Cytotoxic	Resected localised biliary tract cancer, following complete macroscopic resection	III; Open-label	vs. observation	Recruiting; Target	OS	UMIN000011688
Apatinib	VEGFR2	Resected biliary tract cancer	II; Open-label	Apatinib plus capecitabine vs. capecitabine	Not yet recruiting; Target	PFS	NCT03609489
Nivolumab+cabrilizumab	PD1; CSF1	Confirmed biliary tract cancer	II; Single-arm	Nivolumab+cabrilizumab	Not yet recruiting; Target	Drug-related toxicity	NCT03768531

GEM/CIS: gemcitabine+cisplatin; GEMCAP: gemcitabine+capecitabine; DFS: disease-free survival; OS: overall survival; VEGFR2: vascular endothelial growth factor receptor 2; PFS: progression-free survival; PD1: programmed death 1; CSF1: colony-stimulating factor 1.