Background:Esophageal cancer(EC)is the seventh most prevalent cancer and the sixth most common cause of cancer-related mortalities worldwide.Camrelizumab,a monoclonal antibody,has demonstrated moderate efficacy in eso...Background:Esophageal cancer(EC)is the seventh most prevalent cancer and the sixth most common cause of cancer-related mortalities worldwide.Camrelizumab,a monoclonal antibody,has demonstrated moderate efficacy in esophageal squamous cell carcinoma(ESCC).Lactobacillus paracasei,a probiotic bacterium,has a complementary effect in immunotherapy.This study aimed to evaluate the combination of camrelizumab and L.paracasei for advanced ESCC.Methods:This single-arm,single-center,exploratory trial was conducted at the First Affiliated Hospital of Zhengzhou University,Zhengzhou,China.Eligible patients received 200 mg camrelizumab biweekly and two bags of L.paracasei twice daily.The primary endpoint was progression-free survival(PFS),and the secondary endpoints were disease control rate(DCR),overall survival(OS),objective response rate(ORR),and adverse events(AEs).Results:From May 2020 to October 2022,ten patients with advanced ESCC who did not respond to first-line therapy were admitted.At the data cutoff date(August 9,2023),the median follow-up duration was 12 months.Two of 10(20%)achieved objective responses.The median survival was 7.5 months and the median OS was not reached.Grade 3 treatment-related AEs occurred in two of the 10 patients(20%).No serious treatmentrelated AEs or deaths occurred.Conclusions:Camrelizumab combined with L.paracasei showed favorable anticancer activity and may be a viable second-line treatment for patients with ESCC.展开更多
基金supported by the Henan Provincial Health Commission Program for Young and Middle-aged Discipline Leaders(No.HNSWJW-2022026)the Outstanding Youth Talent Program of the Henan Provincial Health Commission(No.YXKC2022039).
文摘Background:Esophageal cancer(EC)is the seventh most prevalent cancer and the sixth most common cause of cancer-related mortalities worldwide.Camrelizumab,a monoclonal antibody,has demonstrated moderate efficacy in esophageal squamous cell carcinoma(ESCC).Lactobacillus paracasei,a probiotic bacterium,has a complementary effect in immunotherapy.This study aimed to evaluate the combination of camrelizumab and L.paracasei for advanced ESCC.Methods:This single-arm,single-center,exploratory trial was conducted at the First Affiliated Hospital of Zhengzhou University,Zhengzhou,China.Eligible patients received 200 mg camrelizumab biweekly and two bags of L.paracasei twice daily.The primary endpoint was progression-free survival(PFS),and the secondary endpoints were disease control rate(DCR),overall survival(OS),objective response rate(ORR),and adverse events(AEs).Results:From May 2020 to October 2022,ten patients with advanced ESCC who did not respond to first-line therapy were admitted.At the data cutoff date(August 9,2023),the median follow-up duration was 12 months.Two of 10(20%)achieved objective responses.The median survival was 7.5 months and the median OS was not reached.Grade 3 treatment-related AEs occurred in two of the 10 patients(20%).No serious treatmentrelated AEs or deaths occurred.Conclusions:Camrelizumab combined with L.paracasei showed favorable anticancer activity and may be a viable second-line treatment for patients with ESCC.