RT Journal Article
SR Electronic
T1 Camrelizumab plus gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary tract cancer: a single-arm, open-label, phase II trial
JF Journal for ImmunoTherapy of Cancer
JO J Immunother Cancer
FD BMJ Publishing Group Ltd
SP e001240
DO 10.1136/jitc-2020-001240
VO 8
IS 2
A1 Chen, Xiaofeng
A1 Wu, Xiaofeng
A1 Wu, Hao
A1 Gu, Yanhong
A1 Shao, Yang
A1 Shao, Qianwen
A1 Zhu, Feipeng
A1 Li, Xiao
A1 Qian, Xiaofeng
A1 Hu, Jun
A1 Zhao, Fengjiao
A1 Mao, Weidong
A1 Sun, Jing
A1 Wang, Jian
A1 Han, Gaohua
A1 Li, Changxian
A1 Xia, Yongxiang
A1 Seesaha, Poshita Kumari
A1 Zhu, Dongqin
A1 Li, Huajun
A1 Zhang, Junling
A1 Wang, Guoqiang
A1 Wang, Xuehao
A1 Li, Xiangcheng
A1 Shu, Yongqian
YR 2020
UL http://jitc.bmj.com/content/8/2/e001240.abstract
AB Background Immune checkpoint inhibitors monotherapy has been studied in patients with advanced biliary tract cancer (BTC). The aim of this study was to assess the efficacy and safety of camrelizumab, plus gemcitabine and oxaliplatin (GEMOX) as first-line treatment in advanced BTC and explored the potential biomarkers associated with response.Methods In this single-arm, open-label, phase II study, we enrolled stage IV BTC patients. Participants received camrelizumab (3 mg/kg) plus gemcitabine (800 mg/m2) and oxaliplatin (85 mg/m2). Primary endpoints were 6-month progression-free survival (PFS) rate and safety. Secondary endpoints were objective response rate (ORR), PFS and overall survival (OS). Exploratory endpoints included association between response and tumor mutational burden (TMB), blood TMB, dynamic change of ctDNA and immune microenvironment.Results 54 patients with advanced BTC were screened, of whom 38 eligible patients were enrolled. One patient withdrew informed consent before first dose treatment. Median follow-up was 11.8 months. The 6-month PFS rate was 50% (95% CI 33 to 65). Twenty (54%) out of 37 patients had an objective response. The median PFS was 6.1 months and median OS was 11.8 months. The most common treatment-related adverse events (TRAEs) were fatigue (27 (73%)) and fever (27 (73%)). The most frequent grade 3 or worse TRAEs were hypokalemia (7 (19%)) and fatigue (6 (16%)). The ORR was 80% in patients with programmed cell death ligand-1 (PD-L1) tumor proportion score (TPS) ≥1% versus 53.8% in PD-L1 TPS <1%. There was no association between response and TMB, blood TMB, immune proportion score or immune cells (p>0.05), except that PFS was associated with blood TMB. Patients with positive post-treatment ctDNA had shorter PFS (p=0.007; HR, 2.83; 95% CI 1.27 to 6.28).Conclusion Camrelizumab plus GEMOX showed a promising antitumor activity and acceptable safety profile as first-line treatment in advanced BTC patients. Potential biomarkers are needed to identify patients who might respond to camrelizumab plus GEMOX.Trial registration number NCT03486678.All data relevant to the study are included in the article or uploaded as supplementary information. no.