First-line camrelizumab(a PD-1 inhibitor)plus apatinib(an VEGFR-2 inhibitor)and chemotherapy for advanced gastric cancer(SPACE):a phase 1 study  

作　　者：Xiaofeng Chen Hao Xu Xiaobing Chen Tongpeng Xu Yitong Tian Deqiang Wang Fen Guo Kangxin Wang Guangfu Jin Xiao Li Rong Wang Fengyuan Li Yongbin Ding Jie Tang Yueyu Fang Jing Zhao Liang Liu Ling Ma Lijuan Meng Zhiguo Hou Rongrong Zheng Yang Liu Ni Guan Bei Zhang Shuang Tong Shiqing Chen Xing Li Yongqian Shu 

机构地区：[1]Department of Oncology,The First Affiliated Hospital with Nanjing Medical University,Nanjing,China [2]Gusu School,Nanjing medical University,Suzhou,China [3]Jiangsu Key Lab of Cancer Biomarkers,Prevention and Treatment,Collaborative Innovation Center for Cancer Personalized Medicine,Nanjing Medical University,Nanjing,China [4]Department of General surgery,The First Affiliated Hospital with Nanjing Medical University,Nanjing,China [5]Department of Oncology,Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University,Zhengzhou,China [6]Henan Engineering Research Center of Precision Therapy of Gastrointestinal Cancer&Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer,Zhengzhou,China [7]Department of Oncology,Digestive Disease Institute&Cancer Institute of Jiangsu University,Affiliated Hospital of Jiangsu University,Zhenjiang,China [8]Department of Oncology,Suzhou Hospital of Nanjing Medical University,Suzhou,China [9]Department of Oncology,Nanjing PuKou People’s Hospital,Nanjing,China [10]Department of Epidemiology,School of Public Health,Nanjing Medical University,Nanjing,China [11]Department of Pathology,The First Affiliated Hospital with Nanjing Medical University,Nanjing,China [12]Department of general surgery,Jurong Branch hospital of Jiangsu Province People Hospital,Jurong,China [13]Department of Medical Oncology,Liyang People’s Hospital,Liyang,China [14]Department of radiology,Nanjing PuKou People’s Hospital,Nanjing,China [15]Jiangsu Hengrui Pharmaceuticals,Shanghai,China [16]Department of Medical Affairs,3D Medicines Inc.,Shanghai,China [17]Shanghai OrigiMed Co.,Ltd.,Shanghai,China

出　　处：《Signal Transduction and Targeted Therapy》2024年第4期1760-1767,共8页信号转导与靶向治疗（英文）

基　　金：funded by the Jiangsu Province 333 High Level Talents Project,the Beijing Xisike Clinical Oncology Research Foundation (Y-HR2019-0367);the National Natural Science Foundation of China (82102981);the Pukou District Social Cause Science and Technology Development Project in 2020 (S2020-21);the Pukou Branch Hospital of Jiangsu Province Hospital (Nanjing Pukou Central Hospital)General Project of Science and Technology Development Fund in 2021 (KJ2021-22);the Pukou Branch Hospital of Jiangsu Province Hospital (Nanjing Pukou Central Hospital)Major Project of Science and Technology Development Fund in 2021 (KJ2021-1);Jiangsu Hengrui Pharmaceuticals.

摘　　要：Patients with advanced gastric cancer typically face a grim prognosis.This phase 1a(dose escalation)and phase 1b(dose expansion)study investigated safety and efficacy of first-line camrelizumab plus apatinib and chemotherapyfor advanced gastric or gastroesophageal junction adenocarcinoma.The primary endpoints included maximum tolerated dose(MTD)in phase 1a and objective response rate(ORR)across phase 1a and 1b.Phase 1a tested three dose regimens of camrelizumab,apatinib,oxaliplatin,and S-1.Dose regimen 1:camrelizumab 200 mg on day 1,apatinib 250 mg every other day,oxaliplatin 100 mg/m^(2) on day 1,and S-140 mg twice a day on days 1-14.Dose regimen 2:same as dose regimen 1,but oxaliplatin 130mg/m.Dose regimen3:same as dose regimen 2,but apatinib 250 mg daily.Thirty-four patients were included(9 in phase 1a,25 in phase 1b).No dose-limiting toxicities occurred so no MTD was identified.Dose 3 was set for the recommended phase 2 doses and administered in phase 1b.The confrmed ORR was 76.5%(95%CI 58.8-89.3).The median progression-free survival was 8.4 months(95%CI 5.9-not evaluable[NE]),and the median overall survival(OS)was not mature(11.6-NE).Ten patients underwent surgery after treatment and the multidisciplinary team evaluation.Among 24 patients without surgery,the median OS was 19.6 months(7.8-NE).Eighteen patients(52.9%)developed grade≥3 treatment-emergent adverse events.Camrelizumab plus apatinib and chemotherapy showed favorable clinical outcomes and manageable safety for untreated advanced gastric cancer(ChiCTR2000034109).

关 键 词：REGIMEN cancer doses 

分 类 号：R730.53[医药卫生—肿瘤]