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    Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/14509


    Title: A phase II trial of nivolumab, gemcitabine and S-1 as the frst-line treatment in patients with biliary tract cancer
    Authors: Chen, MH;Chiang, NJ;Bai, LY;Huang, CJ;Chen, SC;Hsiao, CF;Shan, YS;Su, YY;Chen, LT
    Contributors: National Institute of Cancer Research;Institute of Population Health Sciences
    Abstract: Background: The regimen of modified gemcitabine and S-1 (GS) is active and safe for patients with advanced biliary tract cancer (ABTC) in our previous study. Herein, we report the results of a single arm phase II of Nivolumab plus modified GS as the first-line treatment in ABTC patients. (Trial registration number NCT04172402, TCOG T1219 study). Methods: Patients with chemo-naive ABTC were eligible to receive nivolumab 240 mg and 800 mg/m2 gemcitabine on day 1 plus daily 80/100/120 mg of S-1 (based on body surface area) days 1-10, in a 2-week cycle. Tumor response was assessed by CT/MRI every 6 weeks according to RECIST v1.1. The PR should be confirmed by two consecutive image examinations. Results: Between December 2019 and June 2021, totally 48 patients were enrolled. After a median of 12.2 months (95%CI 9.2-15.3) follow-up, 1 patient got pathological CR and 20 patients achieved confirmed PR. The ORR was 43.8% with additional 21 patients (43.8%) of stable disease and a long-term disease control rate of 79.2%(CR+PR+SD>12weeks). The median progression-free survival and overall survival was 9.1 (95% CI, 7.4-not reached) and not reached (95% CI, 7.4-not reached) months, respectively. All grade 3/4 chemotherapy-related adverse events (AEs) were less than 10%, expect fatigue (14.6%) and skin rash (10.4%). Fourteen patients (35.4%) experienced immune-related AEs with skin toxicity (20.8%), hypothyroidism (8.3%), hypophysitis (8.3%) and pneumonitis (6.3%). Two patients with grade 3 pneumonitis recovered well without any treatment-related death. Correlative studies, including PDL1 expression (CPS, Dako22C3) and Next generation sequencing (ACT Onco plus) will be presented in the JSMO meeting. Conclusions: Nivolumab in combination with modified GS is a promising regimen with good safety profiles, which deserves further investigation for the management of Asian ABTC patients
    Date: 2022-07
    Relation: Annals of Oncology. 2022 Jul;33(Suppl. 6):S478.
    Link to: http://dx.doi.org/10.1016/j.annonc.2022.05.054
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000834940400193
    Appears in Collections:[陳立宗] 會議論文/會議摘要
    [蘇勇曄] 會議論文/會議摘要
    [蕭金福] 會議論文/會議摘要
    [姜乃榕] 會議論文/會議摘要

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