{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T02:03:52Z","timestamp":1792202632345,"version":"4.4.0"},"reference-count":28,"publisher":"American Association for the Advancement of Science (AAAS)","issue":"11","license":[{"start":{"date-parts":[[2021,10,19]],"date-time":"2021-10-19T00:00:00Z","timestamp":1634601600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"RemeGen Co., Ltd"},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["91959205"],"award-info":[{"award-number":["91959205"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Commun"],"published-print":{"date-parts":[[2021,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p xml:lang=\"en\">Current treatment options for human epidermal growth factor receptor 2 (HER2)\u2010overexpressing gastric cancer at third\u2010line have shown limited clinical benefit. Further, there is no specific treatment for HER2 immunohistochemistry (IHC) 2+ and fluorescence in\u2010situ hybridization\u2010negative patients. Here, we report the efficacy and safety of a novel anti\u2010HER2 antibody RC48 for patients with HER2\u2010overexpressing, advanced gastric or gastroesophageal junction cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p xml:lang=\"en\">Patients with HER2\u2010overexpressing (IHC 2+ or 3+), locally advanced or metastatic gastric or gastroesophageal junction cancer who were under at least second\u2010line therapy were eligible and received RC48 2.5 mg\/kg alone every 2 weeks. The primary endpoint was the objective response rate (ORR) assessed by an independent review committee. Secondary endpoints included progression\u2010free survival (PFS), overall survival (OS), duration of response, time to progression, disease control rate, and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p xml:lang=\"en\">Of 179 patients screened, 125 were eligible and received RC48 treatment. The ORR was 24.8% (95% confidence interval [CI]: 17.5%\u201033.3%). The median PFS and OS were 4.1 months (95% CI: 3.7\u20104.9 months) and 7.9 months (95% CI: 6.7\u20109.9 months), respectively. The most frequently reported adverse events were decreased white blood cell count (53.6%), asthenia (53.6%), hair loss (53.6%), decreased neutrophil count (52.0%), anemia (49.6%), and increased aspartate aminotransferase level (43.2%). Serious adverse events (SAEs) occurred in 45 (36.0%) patients, and RC48\u2010related SAEs were mainly decreased neutrophil count (3.2%). Seven patients had adverse events that led to death were not RC48\u2010related.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p xml:lang=\"en\">RC48 showed promising activity with manageable safety, suggesting potential application in patients with HER2\u2010overexpressing, advanced gastric or gastroesophageal junction cancer who have previously received at least two lines of chemotherapy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cac2.12214","type":"journal-article","created":{"date-parts":[[2021,10,21]],"date-time":"2021-10-21T07:22:00Z","timestamp":1634800920000},"page":"1173-1182","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":200,"title":["Efficacy and safety of a novel anti\u2010HER2 therapeutic antibody RC48 in patients with HER2\u2010overexpressing, locally advanced or metastatic gastric or gastroesophageal junction cancer: a single\u2010arm phase II study"],"prefix":"10.34133","volume":"41","author":[{"given":"Zhi","family":"Peng","sequence":"first","affiliation":[{"name":"Peking University Cancer Hospital & Institute","place":["Beijing, P. R. China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tianshu","family":"Liu","sequence":"additional","affiliation":[{"name":"Affiliated Zhongshan Hospital of Fudan University","place":["Shanghai, P. R. China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia","family":"Wei","sequence":"additional","affiliation":[{"name":"the Affiliated Hospital of Nanjing University Medical School","place":["Nanjing, P. R. China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Airong","family":"Wang","sequence":"additional","affiliation":[{"name":"Weihai Municipal Hospital","place":["Weihai, P. R. China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yifu","family":"He","sequence":"additional","affiliation":[{"name":"Anhui Provincial Cancer Hospital","place":["Hefei, P. R. 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China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhen","family":"Li","sequence":"additional","affiliation":[{"name":"Linyi Cancer Hospital","place":["Linyi, P. R. China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kangsheng","family":"Gu","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Anhui Medical University","place":["Hefei, P. R. China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianwei","family":"Lu","sequence":"additional","affiliation":[{"name":"Jiangsu Cancer Hospital","place":["Nanjing, P. R. China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianming","family":"Xu","sequence":"additional","affiliation":[{"name":"The Fifth Medical Center of PLA General Hospital","place":["Beijing, P. R. 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China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuping","family":"Sun","sequence":"additional","affiliation":[{"name":"Jinan Central Hospital","place":["Jinan, P. R. China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guohua","family":"Yu","sequence":"additional","affiliation":[{"name":"Weifang People's Hospital","place":["Weifang, P. R. China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunmei","family":"Bai","sequence":"additional","affiliation":[{"name":"Peking Union Medical College Hospital","place":["Beijing, P. R. China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yong","family":"Liu","sequence":"additional","affiliation":[{"name":"Xuzhou Central Hospital","place":["Xuzhou, P. R. 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China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chao","family":"Gao","sequence":"additional","affiliation":[{"name":"The Affiliated Hospital of Xuzhou Medical University","place":["Xuzhou, P. R. China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0802-1677","authenticated-orcid":false,"given":"Yongqian","family":"Shu","sequence":"additional","affiliation":[{"name":"Jiangsu Province Hospital","place":["Nanjing, P. R. China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dong","family":"Ma","sequence":"additional","affiliation":[{"name":"Guangdong Provincial People's Hospital","place":["Guangzhou, P. R. China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guanghai","family":"Dai","sequence":"additional","affiliation":[{"name":"Chinese PLA General Hospital","place":["Beijing, P. R. 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