Clinical and biomarker analyses of sintilimab plus gemcitabine and cisplatin as first-line treatment for patients with advanced biliary tract cancer

Tian-mei Zeng, Guang Yang, Cheng Lou, Wei Wei, Chen-jie Tao, Xi-yun Chen, Qin Han, Zhuo Cheng, Pei-pei Shang, Yu-long Dong, He-ming Xu, Lie-ping Guo, Dong-sheng Chen, Yun-jie Song, Chuang Qi, Wang-long Deng and Zhen-gang Yuan ()
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Tian-mei Zeng: Eastern Hepatobiliary Surgery Hospital, Second military medical univercity
Guang Yang: Eastern Hepatobiliary Surgery Hospital, Second military medical univercity
Cheng Lou: Eastern Hepatobiliary Surgery Hospital, Second military medical univercity
Wei Wei: Eastern Hepatobiliary Surgery Hospital, Second military medical univercity
Chen-jie Tao: Eastern Hepatobiliary Surgery Hospital, Second military medical univercity
Xi-yun Chen: Eastern Hepatobiliary Surgery Hospital, Second military medical univercity
Qin Han: Eastern Hepatobiliary Surgery Hospital, Second military medical univercity
Zhuo Cheng: Eastern Hepatobiliary Surgery Hospital, Second military medical univercity
Pei-pei Shang: Eastern Hepatobiliary Surgery Hospital, Second military medical univercity
Yu-long Dong: Eastern Hepatobiliary Surgery Hospital, Second military medical univercity
He-ming Xu: Eastern Hepatobiliary Surgery Hospital, Second military medical univercity
Lie-ping Guo: Eastern Hepatobiliary Surgery Hospital, Second military medical univercity
Dong-sheng Chen: Ltd, The State Key Laboratory of Translational Medicine and Innovative Drug Development
Yun-jie Song: Ltd, The State Key Laboratory of Translational Medicine and Innovative Drug Development
Chuang Qi: Ltd, The State Key Laboratory of Translational Medicine and Innovative Drug Development
Wang-long Deng: Ltd, The State Key Laboratory of Translational Medicine and Innovative Drug Development
Zhen-gang Yuan: Eastern Hepatobiliary Surgery Hospital, Second military medical univercity

Nature Communications, 2023, vol. 14, issue 1, 1-14

Abstract: Abstract The prognosis of biliary tract cancer (BTC) remains unsatisfactory. This single-arm, phase II clinical trial (ChiCTR2000036652) investigated the efficacy, safety, and predictive biomarkers of sintilimab plus gemcitabine and cisplatin as the first-line treatment for patients with advanced BTCs. The primary endpoint was overall survival (OS). Secondary endpoints included toxicities, progression-free survival (PFS), and objective response rate (ORR); multi-omics biomarkers were assessed as exploratory objective. Thirty patients were enrolled and received treatment, the median OS and PFS were 15.9 months and 5.1 months, the ORR was 36.7%. The most common grade 3 or 4 treatment-related adverse events were thrombocytopenia (33.3%), with no reported deaths nor unexpected safety events. Predefined biomarker analysis indicated that patients with homologous recombination repair pathway gene alterations or loss-of-function mutations in chromatin remodeling genes presented better tumor response and survival outcomes. Furthermore, transcriptome analysis revealed a markedly longer PFS and tumor response were associated with higher expression of a 3-gene effector T cell signature or an 18-gene inflamed T cell signature. Sintilimab plus gemcitabine and cisplatin meets pre-specified endpoints and displays acceptable safety profile, multiomics potential predictive biomarkers are identified and warrant further verification.

Date: 2023
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DOI: 10.1038/s41467-023-37030-w

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