[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629411":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":27,"locations":36,"responsibleParty":56,"collaborators":27,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":27,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":27,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":38,"whyStopped":27,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"RC48+SOX","EXPERIMENTAL","Patients will first receive 6 to 8 cycles of treatment with RC48 + SOX",[13,14],"Drug: RC48","Drug: SOX Chemotherapy",{"label":16,"type":17,"description":18,"interventionNames":19},"SOX","ACTIVE_COMPARATOR","Patients will receive 6 to 8 cycles of treatment with SOX",[20],"Drug: SOX(normal)",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","RC48","RC48 2.5mg\u002Fkg iv. ,q3w",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"SOX Chemotherapy","S-1: 40-60 mg\u002Fm², oral administration (p.o.), twice daily (b.i.d.), on Days 1 to 14; repeated every 21 days. Oxaliplatin: 100 mg\u002Fm², intravenous infusion (i.v.gtt.), on Day 1; repeated every 21 days.",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"SOX(normal)","S-1: 40 mg\u002Fm², oral administration (p.o.), twice daily (b.i.d.), on Days 1 to 14; repeated every 21 days. Oxaliplatin: 130 mg\u002Fm², intravenous infusion (i.v.gtt.), on Day 1; repeated every 21 days.",[16],[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Nanjing","Jiangsu","210000","China","CN",{"type":45,"coordinates":46},"Point",[47,48],118.77778,32.06167,{"lat":48,"lon":47},[51],{"name":52,"role":53,"phone":54,"phoneExt":27,"email":55},"Hao Xu","CONTACT","13851530117","hxu@njmu.edu.cn",{"type":57,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100629411","phase-2-disitamab-vedotin-combined-with-sox-regimen-versus-sox-alone-as-adjuvant-therapy-for-her2-moderatehigh-expressing-stage--gastric-cancer-a-prospective-multicenter-randomized-phase--clinical-trial-100629411",false,"NCT07474324","Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderate\u002FHigh Expressing Stage Ⅲ Gastric Cancer: A Prospective, Multicenter, Randomized, Phase Ⅱ Clinical Trial","Inclusion Criteria:\n\n* Aged between 18 and 75 years.\n* Have undergone radical resection with D2 or wider lymph node dissection and achieved R0 resection status.\n* No prior systemic anti-tumor treatment (i.e., neoadjuvant therapy) before surgery.\n* Histopathologically confirmed gastric adenocarcinoma.\n* Pathological stage III gastric and gastroesophageal junction adenocarcinoma patients (according to the 8th edition of the American Joint Committee on Cancer \\[AJCC\\] staging system).\n* HER2 moderate-to-high expression (IHC 3+ or 2+).\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n* Expected survival time ≥ 3 months.\n* Able to understand the study protocol, voluntarily participate in the study, and provide written informed consent;\n* Good compliance and able to cooperate with the treatment regimen specified in this study;\n* Possesses complete imaging and pathological clinical data;\n* Adequate organ and bone-marrow function.\n\nExclusion Criteria:\n\n* Primary stage III gastric or gastroesophageal-junction adenocarcinoma not histologically or cytologically confirmed;\n* Unable to receive disitamab vedotin or SOX chemotherapy;\n* Unable to comply with the required follow-up schedule;\n* Unable to accept the treatment regimen specified in this protocol;\n* Unable or unwilling to undergo mandated response assessments (e.g., CT imaging);\n* Active autoimmune disease;\n* History of psychoactive-substance abuse that cannot be discontinued, or any severe\u002Funcontrolled psychiatric disorder, or any severe\u002Funcontrolled systemic disease;\n* Any concomitant condition that, in the investigator's opinion, poses significant risk to the subject or could compromise study completion;\n* Other malignancies within 5 years before screening, except adequately treated cancers considered cured (e.g., thyroid cancer, cervical carcinoma in situ, basal\u002Fsquamous-cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery);\n* Lactating women;\n* Prior neoadjuvant therapy or intra-operative intraperitoneal chemotherapy.","ALL","18 Years","75 Years",{"count":68,"type":69},124,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","This is a prospective, multicenter, randomized, phase II clinical trial intended to enroll patients with HER2-moderate\u002Fhigh-expressing, pathologically staged stage III gastric cancer who have undergone D2 or more extensive surgery. The study aims to evaluate the preliminary efficacy and safety of disitamab vedotin combined with the SOX regimen versus SOX alone as post-operative adjuvant therapy.",[75],"GC\u002FGEJC",[77,78,24,16],"adjuvant therapy","Gastric Adenocarcinom","2026-03-11",{"date":81,"type":82},"2026-03-16","ACTUAL",{"date":84,"type":69},"2026-03-15",{"date":86,"type":69},"2030-12-31",{"name":5,"class":6},1]