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 |
GEM/CIS × 8 vs. capecitabine × 8 (1 : 1) | Recruiting Target n = 781 |
DFS | NCT02170090 |
| GEM/CAP [AdBTC-1] | Cytotoxic | Resected localised biliary tract cancer, following complete macroscopic resection | III Open-label |
GEMCAP × 8 vs. capecitabine × 8 | Recruiting Target n = 460 |
DFS | NCT03779035 |
| S-1 [JCOG1202, ASCOT] | Cytotoxic | Resected localised biliary tract cancer, following complete macroscopic resection | III Open-label |
S1 × 4 vs. observation | Recruiting Target n = 440 |
OS | UMIN000011688 |
| Apatinib | VEGFR2 | Resected biliary tract cancer | II Open-label |
Apatinib plus capecitabine vs. capecitabine | Not yet recruiting Target n = 40 |
PFS | NCT03609489 |
| Nivolumab+cabrilizumab | PD1; CSF1 | Confirmed biliary tract cancer | II Single-arm |
Nivolumab+cabrilizumab | Not yet recruiting Target n = 16 |
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.