{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T04:54:22Z","timestamp":1781585662427,"version":"3.54.5"},"reference-count":8,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,5,20]],"date-time":"2026-05-20T00:00:00Z","timestamp":1779235200000},"content-version":"vor","delay-in-days":19,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T00:00:00Z","timestamp":1777593600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100014807","name":"Nagoya University Hospital","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100014807","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Zolbetuximab is an anti\u2010claudin18.2 (CLDN18.2) antibody, and the addition of zolbetuximab in combination with fluoropyrimidine and oxaliplatin as a first\u2010line treatment for CLDN18.2\u2010positive and HER2\u2010negative gastric or gastroesophageal junction adenocarcinoma has been shown to improve survival. However, the efficacy and safety of the combination of zolbetuximab with combinations other than fluoropyrimidine and oxaliplatin have not been elucidated. The objective of the present study is to evaluate the feasibility of combination treatment with trifluridine\/tipiracil (FTD\/TPI), which is effective as a third\u2010 or later\u2010line treatment, and zolbetuximab. In this study, 32 patients with CLDN18.2\u2010positive and HER2\u2010negative unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma who received two or more lines of chemotherapy will be recruited. The patients will receive FTD\/TPI (35\u2009mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    twice daily on days 1\u20135 and days 8\u201312 every 4\u2009weeks) plus zolbetuximab (an initial dose of 800\u2009mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    or 400\u2009mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    depending on prior zolbetuximab exposure, followed by 400\u2009mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    every 3\u2009weeks). The primary endpoint is treatment\u2010emergent events leading to the discontinuation of zolbetuximab. The secondary endpoints are the time to treatment failure, progression\u2010free survival, overall survival, response rate, incidence of adverse events, and incidence of Grade 3 or higher adverse events. The results will be used to evaluate the feasibility of the treatment and are expected to be used to evaluate whether future trials can be conducted.\n                  <\/jats:p>","DOI":"10.1002\/cam4.71981","type":"journal-article","created":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T06:34:52Z","timestamp":1779345292000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Feasibility Study of Trifluridine\/Tipiracil and Zolbetuximab as Third\u2010 or Later\u2010Line Chemotherapy for\n                    <scp>CLDN18.2<\/scp>\n                    \u2010Positive and\n                    <scp>HER2<\/scp>\n                    \u2010Negative Gastric or Gastroesophageal Junction Adenocarcinoma: A Study Protocol"],"prefix":"10.1002","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4700-6541","authenticated-orcid":false,"given":"Osamu","family":"Maeda","sequence":"first","affiliation":[{"name":"Department of Clinical Oncology and Chemotherapy Nagoya University Hospital  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chie","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Gastroenterological Surgery Nagoya University Graduate School of Medicine  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiro","family":"Furukawa","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Nagoya University Graduate School of Medicine  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazushi","family":"Miyata","sequence":"additional","affiliation":[{"name":"Division of Surgical Oncology, Department of Surgery Nagoya University Graduate School of Medicine  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dai","family":"Shimizu","sequence":"additional","affiliation":[{"name":"Department of Gastroenterological Surgery Nagoya University Graduate School of Medicine  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shizuki","family":"Sugita","sequence":"additional","affiliation":[{"name":"Division of Surgical Oncology, Department of Surgery Nagoya University Graduate School of Medicine  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koki","family":"Nakanishi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterological Surgery Nagoya University Graduate School of Medicine  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Hirose","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Nagoya University Graduate School of Medicine  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuyuki","family":"Mizuno","sequence":"additional","affiliation":[{"name":"Department of Clinical Oncology and Chemotherapy Nagoya University Hospital  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumie","family":"Kinoshita","sequence":"additional","affiliation":[{"name":"Department of Advanced Medicine Nagoya University Hospital  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yachiyo","family":"Kuwatsuka","sequence":"additional","affiliation":[{"name":"Department of Advanced Medicine Nagoya University Hospital  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiko","family":"Ando","sequence":"additional","affiliation":[{"name":"Department of Advanced Medicine Nagoya University Hospital  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitsuro","family":"Kanda","sequence":"additional","affiliation":[{"name":"Department of Gastroenterological Surgery Nagoya University Graduate School of Medicine  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroki","family":"Kawashima","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Nagoya University Graduate School of Medicine  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuichi","family":"Ando","sequence":"additional","affiliation":[{"name":"Department of Clinical Oncology and Chemotherapy Nagoya University Hospital  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,5,20]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)00620-7"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-023-02465-7"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10120-024-01523-4"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.19.02105"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2022.3707"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(18)30739-3"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2008.19.6618"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2008.16.3212"}],"container-title":["Cancer 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