biostudies-literatureChiang NJNational Health Research Institutes, TaiwanMinistry of Science and TechnologyTaiwan Cancer Clinic Foundation and Melissa Lee Cancer FoundationOno Pharmaceutical Co., Ltd.Taiwan Upper Gastrointestinal Cancers Clinical Trial ConsortiumNational Institute of Cancer ResearchTaiwan Cooperative Oncology Group4248-4257https://www.ebi.ac.uk/biostudies/studies/S-EPMC9527499biostudies-literatureUnknown28(19)<h4>Purpose</h4>Modified gemcitabine and S-1 (GS) is an active regimen 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 (NGS) as first-line treatment in ABTC.<h4>Patients and methods</h4>Patients received 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) on days 1 to 10, in a 2-week cycle. The primary endpoint was the objective response rate (ORR). The correlation between therapeutic efficacy and genetic alterations with signatures identified by targeted next-generation sequencing panels was explored.<h4>Results</h4>Between December 2019 and December 2020, 48 eligible patients were enrolled. After a median of 17.6 mClinical cancer research : an official journal of the American Association for Cancer ResearchImpaired Chromatin Remodeling Predicts Better Survival to Modified Gemcitabine and S-1 plus Nivolumab in Advanced Biliary Tract Cancer: A Phase II T1219 Study.PMC9527499CA-109-PP-72CA-108-PP-67MOST109–2314-B-075–082-MY3CA-110-PP-37C08–022CA-110-PP-22109–2321-B-006–011MOHW110-TDU-B-211–124003CA-109-PP-23Hsiao CFChen LTLee ICBai LYTan KTLee PCHuang CJYeh CNChen SJChiang NJHuang YHHung YPChen MHChao YHuang CYChen SCSu YYShan YSfalseImpaired Chromatin Remodeling Predicts Better Survival to Modified Gemcitabine and S-1 plus Nivolumab in Advanced Biliary Tract Cancer: A Phase II T1219 Study.<h4>Purpose</h4>Modified gemcitabine and S-1 (GS) is an active regimen 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 (NGS) as first-line treatment in ABTC.<h4>Patients and methods</h4>Patients received 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) on days 1 to 10, in a 2-week cycle. The primary endpoint was the objective response rate (ORR). The correlation between therapeutic efficacy and genetic alterations with signatures identified by targeted next-generation sequencing panels was explored.<h4>Results</h4>Between December 2019 and December 2020, 48 eligible patients were enrolled. After a median of 17.6 m2022-01-01T00:00:00Z2022 Oct2026-07-14T21:08:49.299Z2025-04-06T00:53:25.225ZS-EPMC95274993584915110.1158/1078-0432.CCR-22-1152