We aimed to assess the tolerability and efficacy of finotonlimab(an anti-programmed cell death protein-1 antibody)in combination with SCT510,a bevacizumab biosimilar,versus sorafenib in unresectable advanced HCC.This ...We aimed to assess the tolerability and efficacy of finotonlimab(an anti-programmed cell death protein-1 antibody)in combination with SCT510,a bevacizumab biosimilar,versus sorafenib in unresectable advanced HCC.This randomized phase 2 and 3 study(ClinicalTrials.gov,NCT04560894;Chinadrugtrials.org.cn,CTR20201976 and CTR20201974)was performed at 67 hospitals in China.HCC patients(n=398)were included between 11 November 2020 and 28 September 2022.In phase 2,patients received intravenous finotonlimab(200 mg every 3 weeks)combined with SCT510(15 mg/kg every 3 weeks).In phase 3,346 patients were randomized(2:1)to either the finotonlimab plus SCT510(dual-agent)group or the sorafenib group.The median follow-up time for the dual-agent therapy and sorafenib groups was 19.9 and 19.0 months,respectively.Median PFS,assessed by BICR according to RECIST 1.1,was significantly longer in the dual-agent group(7.1 months[95%confidence intervals{CI}:6.1,8.4])than in the sorafenib group(2.9 months[95%CI:2.8,4.1];stratified hazard ratio[HR]:0.5,95%CI:0.38,0.65,p<0.0001).Median OS was also significantly longer in patients receiving finotonlimab plus SCT510(22.1 months[18.6,not available])than in those receiving sorafenib(14.2 months[95%CI:10.2,15.8];HR:0.60[95%CI:0.44,0.81],p<0.0008).Finotonlimab in combination with bevacizumab demonstrated favorable efficacy,in comparison to sorafenib,as a first-line treatment for unresectable HCC,with a manageable safety profile.展开更多
In 2022,gastric cancer(GC)ranked as the fifth most common cancer and the third leading cause of cancer death in China,with 358,672 new cases and 260,372 deaths,accounting for 37.0%and 39.4%of global cases,respectively...In 2022,gastric cancer(GC)ranked as the fifth most common cancer and the third leading cause of cancer death in China,with 358,672 new cases and 260,372 deaths,accounting for 37.0%and 39.4%of global cases,respectively[1].Previous studies have shown that 25.9%and 36.5%of GC patients in China were diagnosed at stages III and IV,respectively,with 5-year overall survival(OS)rates of 33.0%for stage III and 5.5%for stage IV[2,3].展开更多
基金National Science and Technology Major Projects of China[2019ZX09732-001]provided funding.
文摘We aimed to assess the tolerability and efficacy of finotonlimab(an anti-programmed cell death protein-1 antibody)in combination with SCT510,a bevacizumab biosimilar,versus sorafenib in unresectable advanced HCC.This randomized phase 2 and 3 study(ClinicalTrials.gov,NCT04560894;Chinadrugtrials.org.cn,CTR20201976 and CTR20201974)was performed at 67 hospitals in China.HCC patients(n=398)were included between 11 November 2020 and 28 September 2022.In phase 2,patients received intravenous finotonlimab(200 mg every 3 weeks)combined with SCT510(15 mg/kg every 3 weeks).In phase 3,346 patients were randomized(2:1)to either the finotonlimab plus SCT510(dual-agent)group or the sorafenib group.The median follow-up time for the dual-agent therapy and sorafenib groups was 19.9 and 19.0 months,respectively.Median PFS,assessed by BICR according to RECIST 1.1,was significantly longer in the dual-agent group(7.1 months[95%confidence intervals{CI}:6.1,8.4])than in the sorafenib group(2.9 months[95%CI:2.8,4.1];stratified hazard ratio[HR]:0.5,95%CI:0.38,0.65,p<0.0001).Median OS was also significantly longer in patients receiving finotonlimab plus SCT510(22.1 months[18.6,not available])than in those receiving sorafenib(14.2 months[95%CI:10.2,15.8];HR:0.60[95%CI:0.44,0.81],p<0.0008).Finotonlimab in combination with bevacizumab demonstrated favorable efficacy,in comparison to sorafenib,as a first-line treatment for unresectable HCC,with a manageable safety profile.
基金approved by the Independent Ethics Committee of Chinese PLA General Hospital(C2021-102-01)Changzhi People’s Hospital(LSPJ2022006)+17 种基金Fujian Provincial Cancer Hospital(2022-016-01)Cancer Hospital of Shandong First Medical University(SDZLEC2022-042-01)The First People’s Hospital of Changde City(2022-016-01)Jilin Cancer Hospital(202201-011-01)Linyi People’s Hospital(2022-lunlishencha-10)Liaoning Cancer Hospital and Institute(20220205)Shanxi Province Cancer Hospital(YW2022009)Affiliated Cancer Hospital of Zhengzhou University,Henan Cancer Hospital(L2022-Y010-002)Harbin Medical University Cancer Hospital(2022-91)Anhui Provincial Cancer Hospital,The First Affiliated Hospital of University of Science and Technology of China(2022-lunlishencha-08)The Fourth Hospital of Hebei Medical University(2022044)Binzhou Medical University Hospital(2022-001-01)Central Hospital Affiliated to Shandong Medical University(jizhongxinlunlilinshen2022-011-01)Qingdao Central Hospital,University of Health and Rehabilitation Science([Y]SY202200401)Liaocheng People’s Hospital(2022006)Suining Central Hospital(2022-lunliyijian-sy002-01)Yanan University Xianyang Hospital(YDXYEC-YWPJ-2022-5)conducted in accordance with the Declaration of Helsinki and Good Clinical Practices.Written informed consent was obtained from all patients before enrollment.
文摘In 2022,gastric cancer(GC)ranked as the fifth most common cancer and the third leading cause of cancer death in China,with 358,672 new cases and 260,372 deaths,accounting for 37.0%and 39.4%of global cases,respectively[1].Previous studies have shown that 25.9%and 36.5%of GC patients in China were diagnosed at stages III and IV,respectively,with 5-year overall survival(OS)rates of 33.0%for stage III and 5.5%for stage IV[2,3].
