This prospective,nonrandomized,open-label phase 2 trial(Chinese Clinical Trial Registry,ChiCTR2200061906)aimed to evaluate the effectiveness of adding the PD-1 antibody tislelizumab to perioperative chemotherapy in pa...This prospective,nonrandomized,open-label phase 2 trial(Chinese Clinical Trial Registry,ChiCTR2200061906)aimed to evaluate the effectiveness of adding the PD-1 antibody tislelizumab to perioperative chemotherapy in patients with locally advanced gastroesophageal junction adenocarcinoma(GEJA).This study enrolled patients with GEJA clinically staged as cT3-4aNanyM0 or cT1-2N+M0 from October 2022 to June 2023.Eligible patients were administered three preoperative and five postoperative 3-week cycles of treatment with PD-1 antibody tislelizumab plus SOX(S-1 and oxaliplatin)regimen.The primary endpoint was major pathological response(MPR)rate.Thirty-two patients were enrolled.The median age was 60 years(range:28–74 years),and 53.1%(17/32)patients were Siewert Ⅲ type.All patients received at least one cycle of assigned preoperative treatment,and 93.8%(30/32)patients completed three cycles of assigned preoperative tislelizumab and SOX.The R0 resection rate was 96.9%(31/32).MPR,pathological complete response(pCR)of primary tumors and ypT0N0 rates were 50.0%(16/32,95%CI:31.9-68.1%),28.1%(9/32,95%CI:13.7-46.7%)and 25.0%(8/32,95%CI:11.5-43.4%),respectively.The surgical morbidity rate was 15.6%(5/32),and no 30-day mortality was observed.In the preoperative and postoperative treatment periods,the rate of treatment-related grade 3-4 adverse events was 31.2%(10/32).At the date of 7th Jan 2025,8(25.0%)patients occurred recurrence.Therefore,perioperative tislelizumab plus chemotherapy demonstrated significantly improved pathological regression and might be a promising option for patients with locally advanced resectable GEJA.展开更多
基金supported by the Noncommunicable Chronic Diseases-National Science and Technology Major Project(2023ZD0501500 to SQY)National Natural Science Foundation of China(82103586,to RCN,82473358 to SQY)+1 种基金Beijing Xisike Clinical Oncology Research Foundation(Y-HR2022MS-0324,to SQY,Y-2023AZMETQN-0017to RCN,Y-2022METAZMS-0123to YFL)the Guangdong Esophageal Cancer Institute Science and Technology Program(M202210).
文摘This prospective,nonrandomized,open-label phase 2 trial(Chinese Clinical Trial Registry,ChiCTR2200061906)aimed to evaluate the effectiveness of adding the PD-1 antibody tislelizumab to perioperative chemotherapy in patients with locally advanced gastroesophageal junction adenocarcinoma(GEJA).This study enrolled patients with GEJA clinically staged as cT3-4aNanyM0 or cT1-2N+M0 from October 2022 to June 2023.Eligible patients were administered three preoperative and five postoperative 3-week cycles of treatment with PD-1 antibody tislelizumab plus SOX(S-1 and oxaliplatin)regimen.The primary endpoint was major pathological response(MPR)rate.Thirty-two patients were enrolled.The median age was 60 years(range:28–74 years),and 53.1%(17/32)patients were Siewert Ⅲ type.All patients received at least one cycle of assigned preoperative treatment,and 93.8%(30/32)patients completed three cycles of assigned preoperative tislelizumab and SOX.The R0 resection rate was 96.9%(31/32).MPR,pathological complete response(pCR)of primary tumors and ypT0N0 rates were 50.0%(16/32,95%CI:31.9-68.1%),28.1%(9/32,95%CI:13.7-46.7%)and 25.0%(8/32,95%CI:11.5-43.4%),respectively.The surgical morbidity rate was 15.6%(5/32),and no 30-day mortality was observed.In the preoperative and postoperative treatment periods,the rate of treatment-related grade 3-4 adverse events was 31.2%(10/32).At the date of 7th Jan 2025,8(25.0%)patients occurred recurrence.Therefore,perioperative tislelizumab plus chemotherapy demonstrated significantly improved pathological regression and might be a promising option for patients with locally advanced resectable GEJA.
