{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,25]],"date-time":"2026-06-25T16:13:03Z","timestamp":1782403983612,"version":"3.54.5"},"reference-count":16,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2024,2,16]],"date-time":"2024-02-16T00:00:00Z","timestamp":1708041600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,4,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>This study aimed to assess the activity of apatinib plus toripalimab in the second line for patients with advanced gastric or esophagogastric junction cancer (GC\/EGJC).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In this open-label, phase II, randomized trial, patients with advanced GC\/EGJC who progressed after first-line chemotherapy were enrolled and received 250 mg apatinib per day plus 240 mg toripalimab on day 1 per 3 weeks (arm A) or physician\u2019s choice of chemotherapy (PC, arm B). The primary endpoint of this study was the 1-year survival rate. Progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and safety were assessed as secondary endpoints.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Twenty-five patients received apatinib plus toripalimab while 26 were enrolled in arm B. The 1-year survival rates of the 2 groups were 43.3% and 42.3%, respectively (P\u2005=\u2005.903). The PFS was 2.77 versus 2.33 months (P\u2005=\u2005.660). The OS was 8.30 versus 9.88 months (P\u2005=\u2005.539). An objective response was reported in 20.0% of patients in arm A compared to 26.9% in arm B (P\u2005=\u2005.368), respectively. A total of 6 (24.0%) patients experienced adverse events of grade\u2005\u2265\u20053 in arm A, while 9 (34.6%) patients suffered from adverse events of grade\u2005\u2265\u20053 in arm B. No drug-related deaths occurred in either group.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Toripalimab plus apatinib treatment in second-line therapy of advanced GC\/EGJC showed manageable toxicity but did not improve clinical outcomes relative to PC treatment (ClinicalTrials.gov Identifier: NCT04190745).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/oncolo\/oyae005","type":"journal-article","created":{"date-parts":[[2024,2,17]],"date-time":"2024-02-17T10:39:47Z","timestamp":1708166387000},"page":"364-e578","source":"Crossref","is-referenced-by-count":10,"title":["Apatinib Plus Toripalimab (Anti-PD1 Therapy) as Second-Line Therapy in Patients With Advanced Gastric or Esophagogastric Junction Cancer: Results From a Randomized, Open-Label Phase II Study"],"prefix":"10.1093","volume":"29","author":[{"given":"Qing","family":"Wei","sequence":"first","affiliation":[{"name":"Department of Hepato-Pancreato-Biliary and Gastric Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences , Hangzhou , People\u2019s Republic of China"},{"name":"Key Laboratory of Prevention, Diagnosis and Therapy of Upper Gastrointestinal Cancer of Zhejiang Province , Hangzhou , People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoqing","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Hepato-Pancreato-Biliary and Gastric Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences , Hangzhou , People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingjing","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Hepato-Pancreato-Biliary and Gastric Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences , Hangzhou , People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chang","family":"Wang","sequence":"additional","affiliation":[{"name":"Cancer Center, The First Hospital of Jilin University , Changchun , People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weijun","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Radiotherapy, Taizhou Central Hospital , Taizhou, Zhejiang , People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanru","family":"Xie","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Lishui Municipal Central Hospital , Lishui, Zhejiang , People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cong","family":"Luo","sequence":"additional","affiliation":[{"name":"Department of Hepato-Pancreato-Biliary and Gastric Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences , Hangzhou , People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lei","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Hepato-Pancreato-Biliary and Gastric Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences , Hangzhou , People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiadong","family":"Chu","sequence":"additional","affiliation":[{"name":"Department of Clinical Research, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences , Hangzhou , People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Pathology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences , Hangzhou , People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhe","family":"Han","sequence":"additional","affiliation":[{"name":"Radiology Department, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences , Hangzhou , People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanlian","family":"Yang","sequence":"additional","affiliation":[{"name":"Nanopep Biotech. Corp. , Beijing , People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiyuan","family":"Hu","sequence":"additional","affiliation":[{"name":"Nanopep Biotech. Corp. , Beijing , People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qi","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Hepato-Pancreato-Biliary and Gastric Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences , Hangzhou , People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jieer","family":"Ying","sequence":"additional","affiliation":[{"name":"Department of Hepato-Pancreato-Biliary and Gastric Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences , Hangzhou , People\u2019s Republic of China"},{"name":"Key Laboratory of Prevention, Diagnosis and Therapy of Upper Gastrointestinal Cancer of Zhejiang Province , Hangzhou , People\u2019s Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,2,16]]},"reference":[{"key":"2024041017291043700_CIT0001","first-page":"2053","article-title":"Regorafenib plus nivolumab in patients with advanced gastric or colorectal cancer: an open-label, dose-escalation, and dose-expansion phase Ib Trial (REGONIVO, EPOC1603)","volume-title":"J Clin Oncol.","author":"Fukuoka","year":"2020"},{"key":"2024041017291043700_CIT0002","first-page":"1057","article-title":"Lenvatinib plus pembrolizumab in patients with advanced gastric cancer in the first-line or second-line setting (EPOC1706): an open-label, single-arm, phase 2 trial","volume-title":"Lancet Oncol.","author":"Kawazoe","year":"2020"},{"key":"2024041017291043700_CIT0003","first-page":"4438","article-title":"Randomized, open-label, phase III study comparing irinotecan with paclitaxel in patients with advanced gastric cancer without severe peritoneal metastasis after failure of 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KEYNOTE-059 trial","volume-title":"JAMA Oncol","author":"Fuchs","year":"2018"},{"key":"2024041017291043700_CIT0010","first-page":"895","article-title":"Assessment of pembrolizumab therapy for the treatment of microsatellite instability-high gastric or gastroesophageal junction cancer among patients in the KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 clinical trials","volume-title":"JAMA Oncol","author":"Chao","year":"2021"},{"key":"2024041017291043700_CIT0011","first-page":"30","article-title":"Dynamic changes in PD-L1 expression and CD8+ T cell infiltration in non-small cell lung cancer following chemoradiation therapy","volume-title":"Lung Cancer.","author":"Choe","year":"2019"},{"key":"2024041017291043700_CIT0012","first-page":"490","article-title":"Alteration in tumoural PD-L1 expression and stromal CD8-positive tumour-infiltrating lymphocytes after concurrent chemo-radiotherapy for non-small cell lung cancer","volume-title":"Br J Cancer.","author":"Yoneda","year":"2019"},{"key":"2024041017291043700_CIT0013","first-page":"e1438111","article-title":"Dynamic change of PD-L1 expression on circulating tumor cells in advanced solid tumor patients undergoing PD-1 blockade therapy","volume-title":"Oncoimmunology","author":"Yue","year":"2018"},{"key":"2024041017291043700_CIT0014","first-page":"e2227","article-title":"Assessment of PD-L1 expression on circulating tumor cells for predicting clinical outcomes in patients with cancer receiving PD-1\/PD-L1 blockade therapies","volume-title":"The Oncologist","author":"Tan","year":"2021"},{"key":"2024041017291043700_CIT0015","first-page":"515","article-title":"Anti-PD-1 antibody SHR-1210 combined with apatinib for advanced hepatocellular carcinoma, gastric, or esophagogastric junction cancer: an open-label, dose escalation and expansion study","volume-title":"Clin Cancer Res.","author":"Xu","year":"2019"},{"key":"2024041017291043700_CIT0016","first-page":"152","article-title":"Liver metastasis restrains immunotherapy efficacy via macrophage-mediated T cell elimination","volume-title":"Nat Med.","author":"Yu","year":"2021"}],"container-title":["The 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