[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614006":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":30,"collaborators":11,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":11,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":11,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":11,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":11},{"fullName":5,"class":6},"Xijing Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Zanidatamab Combined with Chemotherapy","EXPERIMENTAL",null,[13],"Drug: Zanidatamab Combined with Chemotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Zanidatamab Combined with Chemotherapy","Zanidatamab Combined with Chemotherapy as Neoadjuvant Therapy",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Xiaohua Li","CONTACT","+8619991901686","xįyylixiaohua@163.com",{"name":27,"role":23,"phone":28,"phoneExt":11,"email":29},"Pengfei Yu","+8615249254020","yupengfei8989@163.com",{"type":31,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100614006","phase-2-zanidatamab-combined-with-chemotherapy-as-neoadjuvant-therapy-for-her2-high-expression-ggejc-100614006",false,"NCT07273981","Zanidatamab Combined With Chemotherapy as Neoadjuvant Therapy for HER2-high Expression G\u002FGEJC","Phase II Clinical Study of Zanidatamab Combined With Chemotherapy as Neoadjuvant Therapy for Locally Advanced HER2-high Expression (IHC3+\u002F2+FISH+) Gastric\u002FGastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Histologically\u002Fradiologically confirmed Stage II\u002FIII (cT1-2N+M0 or cT3-4aNanyM0) Siewert II\u002FIII GEJ\u002Fgastric adenocarcinoma.\n3. HER2-high (IHC 3+\u002F2+FISH+); HER2 2+ requires FISH (no time restriction).\n4. Age 18-75, any gender.\n5. ECOG 0-1, surgically eligible.\n6. Adequate organ function for abdominal surgery.\n7. Life expectancy ≥3 months.\n\nExclusion Criteria:\n\nExclusion Criteria\n\n1. Unresectable\u002Fmetastatic (Stage IV) disease.\n2. Prior systemic GC therapy.\n3. Other malignancies within 5 years (except those with \\>90% 5-year survival).\n4. Cardiopulmonary dysfunction.\n5. Major surgery within 4 weeks pre-study.\n6. Severe infection within 4 weeks.\n7. Prior chemo\u002Ftargeted therapy.\n8. Hypersensitivity to study drugs\u002Fexcipients\u002FmAbs.\n9. Factors impairing oral intake (e.g., ≥Grade 2 dysphagia\u002Fchronic diarrhea).\n10. Uncontrolled comorbidities affecting compliance\u002Foutcomes.\n11. Pregnancy\u002Flactation\u002Fplanned pregnancy.\n12. Immunosuppression (\\>10mg\u002Fday prednisone equivalent within 2 weeks).\n13. Active HBV (DNA ≥1×10³ copies\u002FmL or ≥200IU\u002FmL), HCV+, or HIV+.\n14. Other antitumor trials within 28 days.\n15. Other high-risk conditions (e.g., psychiatric disorders) per investigator.\n16. Refusal to sign consent.","ALL","18 Years","75 Years",{"count":43,"type":44},30,"ESTIMATED","INTERVENTIONAL",[47],"PHASE2","HER2 overexpression is observed in approximately 20% of gastric cancers and gastroesophageal junction (GEJ) cancers, making it a validated target for anti-tumor therapy . In advanced-stage systemic therapy, trastuzumab combined with chemotherapy has demonstrated clinical benefits for HER2-positive gastric and GEJ cancers . However, the combination of trastuzumab and pertuzumab plus chemotherapy did not significantly improve overall survival (OS) compared to trastuzumab monotherapy in HER2-expressed gastric\u002FGEJ cancers .\n\nIn neoadjuvant therapy for early-stage or locally advanced gastric cancer, there is currently no standardized perioperative regimen for HER2-positive gastric or GEJ cancers, and effective treatment remains challenging .\n\nZanidatamab, a humanized bispecific IgG1-like antibody targeting HER2's ECD4 and ECD2 epitopes, exhibits unique enhanced functionality . Phase II studies (NCT03929666) showed that zanidatamab combined with chemotherapy as first-line therapy for HER2-positive advanced gastroesophageal adenocarcinoma (GEA) demonstrated superior survival benefits and durable responses compared to standard therapy (trastuzumab plus chemotherapy) . A Phase III study (HERIZON-GEA-01, NCT05152147) is now underway to further validate its efficacy when combined with chemotherapy ± tislelizumab versus trastuzumab-based chemotherapy .\n\nFor previously untreated stage II\u002FIII locally advanced gastroesophageal junction adenocarcinoma (cT1-2N+M0, cT3-4aNanyM0) with confirmed HER2 high expression (HER2 3+\u002F2+ FISH+), neoadjuvant zanidatamab combined with chemotherapy (FLOT\u002FSOX\u002FCAPOX) is being explored to evaluate safety and efficacy, potentially offering a new treatment option for HER2-positive GEJ cancers in perioperative settings .",[50],"Gastric\u002FGastroesophageal Junction Adenocarcinoma","NOT_YET_RECRUITING","2025-12-08",{"date":54,"type":55},"2025-12-10","ACTUAL",{"date":57,"type":44},"2026-01-01",{"date":59,"type":44},"2029-07-31",{"name":5,"class":6}]