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Zeng, Tian-Mei; Yang, Guang; Lou, Cheng; Wei, Wei; Tao, Chen-Jie; Chen, Xi-Yun; Han, Qin; Cheng, Zhuo; Shang, Pei-Pei; Dong, Yu-Long; Xu, He-Ming; Guo, Lie-Ping; Chen, Dong-Sheng; Song, Yun-Jie; Qi, Chuang; Deng, Wang-Long; Yuan, Zhen-Gang
Nature communications, 03/2023, Volume: 14, Issue: 1Journal Article
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.
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