[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621717":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":41,"locations":50,"responsibleParty":76,"collaborators":27,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":27,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":104,"whyStopped":27,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Sichuan University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"SOX","ACTIVE_COMPARATOR","oxaliplatin, S-1, four 3-week cycles were administered.",[13,14],"Drug: Oxaliplatin","Drug: S-1",{"label":16,"type":17,"description":18,"interventionNames":19},"ISOX","EXPERIMENTAL","In the ISOX group, the regimen included ivonescimab, oxaliplatin, and S-1.",[20,13,14],"Drug: Ivonescimab (20mg\u002Fkg Q3W)",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Ivonescimab (20mg\u002Fkg Q3W)","ivonescimab (20 mg\u002Fkg), four 3-week cycles were administered; ivonescimab was not administered in cycle 4. .",[16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Oxaliplatin","Oxaliplatin (130 mg\u002Fm², administered intravenously on day 1), four 3-week cycles were administered.",[16,9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"S-1","S-1 (administered orally twice daily on days 1-14 of each 21-day cycle, with the daily dose determined by body surface area: \\\u003C1.25 m², 80 mg\u002Fday; ≥1.25 to \\\u003C1.5 m², 100 mg\u002Fday; ≥1.5 m², 120 mg\u002Fday), four 3-week cycles were administered.",[16,9],[37],{"name":38,"affiliation":39,"role":40},"Gou Hongfeng","Gastric Cancer Center, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu 610041, Sichuan, China.","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},"Hu Qiancheng, MD","CONTACT","+86-17780026135","hqch860109@163.com",{"name":38,"role":44,"phone":48,"phoneExt":27,"email":49},"+86-18980602292","gouhongfeng1977@wchscu.cn",[51],{"facility":52,"status":27,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"West China Hospital, Sichuan University","Chengdu","Sichuan","610041","China","CN",{"type":59,"coordinates":60},"Point",[61,62],104.06667,30.66667,{"lat":62,"lon":61},[65,69,73],{"name":66,"role":44,"phone":67,"phoneExt":27,"email":68},"Li Na","+86-85422654","namgal515@163.com",{"name":70,"role":44,"phone":71,"phoneExt":27,"email":72},"Chen Shiqi","+86-85423297","905854557@qq.com",{"name":74,"role":75,"phone":27,"phoneExt":27,"email":27},"Gou Hongfeng, MD","SUB_INVESTIGATOR",{"type":40,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Bo Zhang, MD","Chief Physician","100621717","phase-2-perioperative-ivonescimab-plus-s-1-and-oxaliplatin-sox-for-locally-advanced-gastric-or-gej-adenocarcinoma-100621717",false,"NCT07374250","Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) for Locally Advanced Gastric or GEJ Adenocarcinoma","Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) Versus SOX Alone for Locally Advanced Gastric or GEJ Adenocarcinoma: A Multicenter Randomized Phase II Study","Huaxi","Inclusion Criteria:\n\n1. Age 18-75 years.\n2. Histologically confirmed gastric or gastroesophageal junction (G\u002FGEJ) adenocarcinoma.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n4. Clinically staged as T3-4a N+ M0 by computed tomography (CT) or magnetic resonance imaging (MRI).\n5. Considered eligible for curative resection.\n6. No prior antitumor therapy for the current disease.\n7. Adequate organ function, including hepatic, renal, and bone marrow function, as per prespecified laboratory criteria.\n8. Expected survival of ≥6 months.\n\nExclusion Criteria:\n\n1. Known mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumor.\n2. Uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg despite optimized antihypertensive therapy, or hypertension complicated by acute events (e.g., hypertensive crisis, hypertensive encephalopathy) that cannot be stably controlled.\n3. Tumor lesions with a bleeding tendency, including but not limited to: active ulcerative tumor lesions, hematemesis within 2 months prior to informed consent, high risk of major gastrointestinal bleeding as determined by the investigator.\n4. History of thromboembolic or arterial\u002Fvenous vascular events within 6 months prior to enrollment, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism.\n5. Gastrointestinal perforation or gastrointestinal obstruction within 6 months prior to enrollment.","ALL","18 Years","75 Years",{"count":91,"type":92},154,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","The purpose of this clinical trial is to evaluate whether perioperative ivonescimab in combination with S-1 and oxaliplatin (SOX) is effective in treating locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study will also assess the safety profile of this treatment regimen.\n\nPrimary Objective:\n\nTo determine whether perioperative ivonescimab plus SOX improves the pathological complete response (pCR) rate compared with SOX alone in patients with locally advanced gastric or GEJ adenocarcinoma.\n\nStudy Design:\n\nParticipants will be randomly assigned to receive either ivonescimab plus SOX or SOX alone to evaluate the potential added benefit of ivonescimab in this setting.\n\nParticipation Details:\n\nParticipants will receive the assigned treatment (ivonescimab plus SOX or SOX alone) every 21 days for approximately 4 months.\n\nThey will visit the clinic once every 3 weeks for evaluations, laboratory tests, and monitoring.\n\nParticipants will be asked to keep a daily diary to record any symptoms or side effects experienced during the study.",[98,99],"Gastric Cancer","RCT",[101,102,103],"gastric cancer","Ivonescimab","neoadjuvant treatment","NOT_YET_RECRUITING","2026-01-24",{"date":107,"type":108},"2026-01-28","ACTUAL",{"date":110,"type":92},"2026-02-01",{"date":112,"type":92},"2027-12-31",{"name":5,"class":6},1]