biostudies-literatureZhu CCSCO-hengrui Cancer Research FundCAMS Innovation Fund for Medical Sciences (CIFMS)National High Level Hospital Clinical Research FundingCAMS Innovation Fund for Medical SciencesCSCO-MSD Cancer Research FundNational Ten-thousand Talent Program56https://www.ebi.ac.uk/biostudies/studies/S-EPMC11149318biostudies-literatureUnknown12(1)<h4>Background</h4>Accumulating evidence suggests that the gut microbiota and metabolites can modulate tumor responses to immunotherapy; however, limited data has been reported on biliary tract cancer (BTC). This study used metagenomics and metabolomics to identify characteristics of the gut microbiome and metabolites in immunotherapy-treated BTC and their potential as prognostic and predictive biomarkers.<h4>Methods</h4>This prospective cohort study enrolled 88 patients with BTC who received PD-1/PD-L1 inhibitors from November 2018 to May 2022. The microbiota and metabolites significantly enriched in different immunotherapy response groups were identified through metagenomics and LC-MS/MS. Associations between microbiota and metabolites, microbiota and clinical factors, and metabolites anBiomarker researchGut microbiota and metabolites signatures of clinical response in anti-PD-1/PD-L1 based immunotherapy of biliary tract cancer.PMC111493182022-I2M-C&T-A-003NAY-HR2020QN-04142021-I2M-1-0612022-PUMCH-B-1282022-I2M-C&amp;T-A-003Y-HR2020MS-0415Y-HR2019-0239Y-MSDZD2021-02132021-I2M-1-003Ning CZhang DXun ZLiang YChao JLong JZhang NZhang LWang HZhu CLan ZYang XSang XWang SJiang XWang YZhu RXue JZhang CZhao HfalseGut microbiota and metabolites signatures of clinical response in anti-PD-1/PD-L1 based immunotherapy of biliary tract cancer.<h4>Background</h4>Accumulating evidence suggests that the gut microbiota and metabolites can modulate tumor responses to immunotherapy; however, limited data has been reported on biliary tract cancer (BTC). This study used metagenomics and metabolomics to identify characteristics of the gut microbiome and metabolites in immunotherapy-treated BTC and their potential as prognostic and predictive biomarkers.<h4>Methods</h4>This prospective cohort study enrolled 88 patients with BTC who received PD-1/PD-L1 inhibitors from November 2018 to May 2022. The microbiota and metabolites significantly enriched in different immunotherapy response groups were identified through metagenomics and LC-MS/MS. Associations between microbiota and metabolites, microbiota and clinical factors, and metabolites an2024-01-01T00:00:00Z2024 Jun2026-05-03T03:29:00.626Z2026-04-07T18:48:04.001ZS-EPMC111493183883136810.1186/s40364-024-00607-8