Potential utility of liquid biopsies in the management of patients with biliary tract cancers: A review

Table 1 Biliary tract cancer trial list

NCT	Setting	Recruitment status	Expected enrolment number	Relevant intervention	Phase	Relevant liquid biopsy outcomes
NCT04561453	Resected CCA/GBC	Recruiting	20	ctDNA monitoring (interval not stated)	NA	Success rate in obtaining ctDNA. Predictive value of ctDNA for recurrence and response to medical therapy
NCT03377179	Unresectable CCA, 1st or 2nd line	Recruiting	105	ABC294640 + hydroxychloroquine	2	Serial ctDNA monitoring during/after treatment
NCT04484636	Advanced HCC, CCA, GBC, pancreatic, gastric or oesophageal cancer in 1st line therapy	Recruiting	200	FoundationOneCDx. FoundationOneLiquid	NA	Frequency of targetable mutations. Heterogeneity of targetable alterations in paraffin embedded specimen vs cfDNA. Number of patients receiving therapies in accordance to their genomic profiles
NCT04400357	Operable eCCA, ampullary, duodenal or pancreatic cancer	Recruiting	244	Robotic versus open pancreaticoduoedenectomy	NA	Baseline ctDNA. Effect of operative approach on ctDNA at post-operative day 1-30
NCT03278106	Stage 3/4 GBC	Active, not recruiting	28	Trifluridine/tipiracil following at least 1 line of systemic therapy	2	Baseline ctDNA or CTC. Change in ctDNA or CTC during and after treatment
NCT04072445	Advanced GBC	Recruiting	28	Trifluridine/tipiracil + irinotecan following at least 1 line of systemic therapy	2	Baseline ctDNA or CTC. Change in ctDNA or CTC during and after treatment (frequency not stated)
NCT04445532	BTC (any stage), HCC, healthy controls. Ampullary eligibility not stated	Recruiting	450	ctDNA monitoring during standard surgical or systemic therapy	NA	Biomarkers of DFS/OS and treatment efficacy
NCT03718897	BTC newly diagnosed by ERCP	Recruiting	100	Baseline ctDNA and tissue whole genome sequencing	NA	OS
NCT04005339	Advanced BTC (excluding ampullary)	Recruiting	44	1st or 2nd line fluorouracil, leucovorin, liposomal irinotecan	2	ctDNA as surrogate for disease burden. Change in ctDNA compared to CA19-9 (ctDNA frequency not stated)

ClinicalTrials.gov last accessed 20 January 2021. BTC: Biliary tract cancer; CA19-9: Carbohydrate antigen 19-9; CCA: Cholangiocarcinoma; cfDNA: Cell-free DNA; CTC: Circulating tumour cell; ctDNA: Circulating tumour DNA; DFS: Disease-free survival; eCCA: Extrahepatic cholangiocarcinoma; ERCP: Endoscopic retrograde cholangiopancreatography; GBC: Gallbladder cancer; HCC: Hepatocellular carcinoma; OS: Overall survival.