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Study protocol of the C-SOLVE (JACCRO GC-12) trial; a randomized, non-comparative phase II trial of CapeOX or SOX plus zolbetuximab in HER2-negative, CLDN18.2-positive unresectable advanced gastric or esophagogastric junction cancer.

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Title: Study protocol of the C-SOLVE (JACCRO GC-12) trial; a randomized, non-comparative phase II trial of CapeOX or SOX plus zolbetuximab in HER2-negative, CLDN18.2-positive unresectable advanced gastric or esophagogastric junction cancer.
Authors: Yuki S; Department of Cancer Genomics and Precision Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Japan., Kawakami H; Department of Clinical Oncology, Tohoku University Graduate School of Medicine, 4-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Miyagi, Japan. kawakami_h@tohoku.ac.jp., Harada K; Divison of Cancer Center, Hokkaido University Hospital, Sapporo, Japan., Kubota Y; Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan., Pak K; Division of Biostatistics, Department of Data Management, Center for Clinical Research, National Center for Child Health and Development, Tokyo, Japan., Kakeji Y; Division of Gastro-intestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan., Terashima M; Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan., Baba E; Department of Comprehensive Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan., Muro K; Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan., Sunakawa Y; Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan., Ichikawa W; Department of Medical Oncology, Sonoda Daiichi Hospital, Tokyo, Japan., Fujii M; Japan Clinical Cancer Research Organization (JACCRO), Tokyo, Japan.
Source: BMC cancer [BMC Cancer] 2026 Jul 17. Date of Electronic Publication: 2026 Jul 17.
Publication Type: Journal Article
Journal Info: Publisher: BioMed Central Country of Publication: England NLM ID: 100967800 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1471-2407 (Electronic) Linking ISSN: 14712407 NLM ISO Abbreviation: BMC Cancer Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Study protocol of the C-SOLVE (JACCRO GC-12) trial; a randomized, non-comparative phase II trial of CapeOX or SOX plus zolbetuximab in HER2-negative, CLDN18.2-positive unresectable advanced gastric or esophagogastric junction cancer.
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  Data: <searchLink fieldCode="AU" term="%22Yuki+S%22">Yuki S</searchLink>; Department of Cancer Genomics and Precision Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.<br /><searchLink fieldCode="AU" term="%22Kawakami+H%22">Kawakami H</searchLink>; Department of Clinical Oncology, Tohoku University Graduate School of Medicine, 4-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Miyagi, Japan. kawakami_h@tohoku.ac.jp.<br /><searchLink fieldCode="AU" term="%22Harada+K%22">Harada K</searchLink>; Divison of Cancer Center, Hokkaido University Hospital, Sapporo, Japan.<br /><searchLink fieldCode="AU" term="%22Kubota+Y%22">Kubota Y</searchLink>; Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.<br /><searchLink fieldCode="AU" term="%22Pak+K%22">Pak K</searchLink>; Division of Biostatistics, Department of Data Management, Center for Clinical Research, National Center for Child Health and Development, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Kakeji+Y%22">Kakeji Y</searchLink>; Division of Gastro-intestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.<br /><searchLink fieldCode="AU" term="%22Terashima+M%22">Terashima M</searchLink>; Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.<br /><searchLink fieldCode="AU" term="%22Baba+E%22">Baba E</searchLink>; Department of Comprehensive Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.<br /><searchLink fieldCode="AU" term="%22Muro+K%22">Muro K</searchLink>; Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.<br /><searchLink fieldCode="AU" term="%22Sunakawa+Y%22">Sunakawa Y</searchLink>; Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.<br /><searchLink fieldCode="AU" term="%22Ichikawa+W%22">Ichikawa W</searchLink>; Department of Medical Oncology, Sonoda Daiichi Hospital, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Fujii+M%22">Fujii M</searchLink>; Japan Clinical Cancer Research Organization (JACCRO), Tokyo, Japan.
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  Data: <searchLink fieldCode="JN" term="%22100967800%22">BMC cancer</searchLink> [BMC Cancer] 2026 Jul 17. <i>Date of Electronic Publication: </i>2026 Jul 17.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22BioMed+Central%22">BioMed Central </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>100967800 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1471-2407 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2214712407%22">14712407 </searchLink><i>NLM ISO Abbreviation: </i>BMC Cancer <i>Subsets: </i>MEDLINE
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        Value: 10.1186/s12885-026-16478-1
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      – TitleFull: Study protocol of the C-SOLVE (JACCRO GC-12) trial; a randomized, non-comparative phase II trial of CapeOX or SOX plus zolbetuximab in HER2-negative, CLDN18.2-positive unresectable advanced gastric or esophagogastric junction cancer.
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              Text: 2026 Jul 17
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