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Background The association of contrast-enhanced MRI (CE-MRI) and the overall survival (OS) of biliary tract cancers (BTC) is ambiguous. Thus, the aim of this study is to evaluate the value of signal enhancement ratio (SER) and its early change in CE-MRI as biomarkers of survival after hepatic arterial infusion chemotherapy (HAIC) in BTC. Results One hundred and two BTC patients treated via HAIC with 3cir-OFF regimen between January 2011 and June 2020 were enrolled in this retrospective study. The median progression-free survival (PFS) and OS were 9.8 months [range 1.5–83.3 months, 95% confidence interval (CI) 7.789–11.811] and 14.2 months (range 1.8–83.3 months, 95% CI: 11.106–17.294), respectively. The cutoff value of SER before HAIC (SER0) was 1.04, and both median PFS and OS in the SER0 ≥ 1.04 group were longer than in the SER0 < 1.04 group (median PFS: 10.5 vs. 8.5 months, p = 0.027; median OS: 23.9 vs. 12.3 months, p < 0.001). The median OS in the ΔSER > 0 group was longer than in the ΔSER < 0 group (17.3 versus 12.8 months, p = 0.029 (ΔSER means the change of SER after two cycles of HAIC). Multivariate analysis showed SER0 (p = 0.029) and HAIC treatment cycle (p = 0.002) were independent predictors of longer survival. Conclusions SER in CE-MRI before HAIC (SER0) is a potential biomarker for the prediction of survival after HAIC in advanced BTC.

Background: Combination of checkpoint inhibitors (CPIs) with anti-angiogenic agents are emerging as potential novel treatment options of hepatocellular carcinoma (HCC).Here we assessed the efficacy and safety of C+A in patients (pts) with advanced HCC.Methods: This phase II study was conducted at 25 study sites in China. Pts with advanced HCC, treatment-naive or failure to sorafenib or donafenib were enrolled. Pts received intravenous C 200 mg every 2 weeks plus A 250 mg qd. The primary endpoint was objective response assessed by independent central review per RECIST v1.1.Results: From Mar 2018 to Jan 2019, 70 pts in first-line setting and 120 pts in secondline setting were enrolled and received treatment of C+A. 168 (88%) of 190 pts were with HBV infection. As of Jan, 2020, median follow-up was 16.7 months and 14.0 months in the first-line and second-line treatment cohort, respectively. The objective response rate (ORR) assessed by independent central review per RECIST v1.1 was 34% and 23%; ORR assessed by independent central review per mRECIST was 46% and 25%; the 12-month overall survival (OS) rate was 75% and 68%, respectively. As of Apr 2020, the 18-month OS rate was 58% in the first-line cohort (table). Overall, 147 (77%) pts had grade 3 treatment-related AEs, with the most common being hypertension (34%), and increased g-GT (12%). Twenty-three (12%) pts discontinued the treatment of either drug due to a treatment-related AE.Conclusions: C+A provided high ORR, durable response with a manageable safety profile in advanced HCC pts. Notably, the remarkable survival benefit might suggest C+A is a promising strategy in advanced HCC pts.Clinical trial identification: NCT03463876.