[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654619":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":29,"studyPopulation":29,"armGroups":36,"interventions":46,"overallOfficials":29,"centralContacts":29,"locations":56,"responsibleParty":76,"collaborators":29,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":29,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":29,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":29,"overallStatus":97,"whyStopped":29,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Pathological Complete Response (pCR)","Proportion of subjects achieving CAP Tumor Regression Grade 0 (TRG0), defined as no viable malignant cells detected in primary gastric tumor and all regional lymph nodes after radical D2 gastrectomy","after surgery，within approximately 4-6 weeks",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"R0 Resection Rate","The proportion of subjects who achieve R0 resection confirmed by postoperative surgical pathology.","within approximately 2 weeks after surgery",{"measure":19,"description":20,"timeFrame":21},"Event-Free Survival (EFS)","EFS is the time from date of randomization until the date of disease progression or death.(assessed by the investigator per RECIST v1.1 criteria)","Up to 5 years",{"measure":23,"description":24,"timeFrame":21},"Overall Survival (OS)","Overall survival is length of time from randomization until the date of death due to any cause.",{"measure":26,"description":27,"timeFrame":28},"Incidence, severity and causality of TEAEs, SAEs graded by NCI-CTCAE 6.0.","Assessment of safety","From first study drug to 90 days after last drug administration",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":29},"NONE",[37,42],{"label":38,"type":39,"description":29,"interventionNames":40},"Cohort 1: Trastuzumab Rezetecan + Retlirafusp alfa + CAPOX Perioperative Therapy + Retlirafusp Alfa","EXPERIMENTAL",[41],"Drug: Trastuzumab Rezetecan + Retlirafusp alfa + CAPOX",{"label":43,"type":39,"description":29,"interventionNames":44},"Cohort 2: Trastuzumab Rezetecan + Retlirafusp Alfa (Without Chemotherapy) Perioperative Therapy + Re",[45],"Drug: Trastuzumab Rezetecan + Retlirafusp Alfa",[47,52],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":29},"DRUG","Trastuzumab Rezetecan + Retlirafusp alfa + CAPOX","1. Drug: Trastuzumab Rezetecan Description: IV infusion Q3W; Cycle 1 loading dose 6.4 mg\u002Fkg, subsequent cycles 4.8 mg\u002Fkg; administered for 3 neoadjuvant cycles and 3 adjuvant cycles\n2. Drug: Retlirafusp alfa Description: IV infusion 1800 mg Q3W; 3 neoadjuvant, 3 adjuvant cycles, then single-agent maintenance up to total 17 cycles\n3. Drug: Oxaliplatin Description: 60 mg\u002Fm² IV Q3W, only 3 neoadjuvant cycles\n4. Drug: Capecitabine Description: 750 mg\u002Fm² oral twice daily, 2 weeks on \u002F 1 week off; 3 neoadjuvant + 3 adjuvant cycles\n5. Procedure: Radical D2 Gastrectomy Description: R0 curative resection performed 3-6 weeks post final neoadjuvant dose",[38],{"type":48,"name":53,"description":54,"armGroupLabels":55,"otherNames":29},"Trastuzumab Rezetecan + Retlirafusp Alfa","1. Drug: Trastuzumab Rezetecan Description: IV infusion Q3W; Cycle 1 loading dose 6.4 mg\u002Fkg, subsequent cycles 4.8 mg\u002Fkg; administered for 3 neoadjuvant cycles and 3 adjuvant cycles\n2. Drug: Retlirafusp alfa Description: IV infusion 1800 mg Q3W; 3 neoadjuvant, 3 adjuvant cycles, then single-agent maintenance up to total 17 cycles\n3. Procedure: Radical D2 Gastrectomy Description: R0 curative resection performed 3-6 weeks post final neoadjuvant dose",[43],[57],{"facility":58,"status":29,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Tianjin Medical University Cancer Institute & Hospital","Tianjin","Tianjin Municipality","300000","China","CN",{"type":65,"coordinates":66},"Point",[67,68],117.17667,39.14222,{"lat":68,"lon":67},[71],{"name":72,"role":73,"phone":74,"phoneExt":29,"email":75},"Liangliang Wu","CONTACT","13752273612","wuliangliang830996@126.com",{"type":77,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100654619","phase-2-phase-ii-study-of-trastuzumab-rezetecan-combined-with-retlirafusp-alfa-with-or-without-capox-as-perioperative-therapy-for-resectable-locally-advanced-gastricgastroesophageal-junction-adenocarcinoma-100654619",false,"NCT07802288","Phase II Study of Trastuzumab Rezetecan Combined With Retlirafusp Alfa With or Without CAPOX as Perioperative Therapy for Resectable Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","A Multicenter, Randomized Phase II Study of Trastuzumab Rezetecan Combined With Retlirafusp Alfa With or Without CAPOX Regimen for Perioperative Treatment of Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Voluntarily sign written informed consent before any study-related procedures\n2. Age ≥18 and ≤75 years old\n3. Histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma\n4. AJCC 8th edition stage II-III resectable disease (cT1-2N+M0, T3-4aNanyM0); negative peritoneal cytology (CY0) confirmed by pre-study laparoscopy\n5. HER2 expression status: High HER2 (IHC 3+ or IHC 2+ FISH-positive) OR Low\u002FIntermediate HER2 (IHC 2+ FISH-negative \u002F IHC 1+)\n6. No prior systemic anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, radiotherapy, radical gastrectomy)\n7. Planned radical D2 gastrectomy after neoadjuvant treatment completion\n8. Able to swallow oral capecitabine tablets intact\n9. ECOG Performance Status 0 or 1\n10. Estimated overall survival ≥12 months\n11. Adequate organ function (no blood products\u002FG-CSF within prior 14 days):\n\n    * ANC ≥1.5×10⁹\u002FL; PLT ≥80×10⁹\u002FL; Hb ≥90 g\u002FL\n    * Total bilirubin \\\u003C1.5×ULN; ALT\u002FAST ≤2.5×ULN\n    * Serum Cr ≤1.5×ULN or CrCl \\>50 mL\u002Fmin\n    * INR, PT, APTT ≤1.5×ULN\n12. Fertile female subjects: Negative serum pregnancy test within 72 hours before first dose; all fertile participants agree to effective contraception during treatment and required post-treatment contraceptive window\n\nExclusion Criteria:\n\n1. Siewert type I GEJ tumor or Siewert II tumor requiring cervicothoracic surgical approach\n2. Confirmed peritoneal metastasis, positive peritoneal cytology (CY1), or AJCC T4b disease\n3. Tumor unresectable or absolute contraindication to radical gastrectomy\n4. History of other malignant tumor within past 5 years (excluding cured basal cell skin carcinoma, cervical\u002Fbreast carcinoma in situ)\n5. Uncontrolled hypertension (SBP≥160 mmHg or DBP≥100 mmHg despite optimal medical management)\n6. Cardiac dysfunction: NYHA grade ≥2 heart failure, LVEF \\\u003C50%, unstable angina, myocardial infarction within 1 year, prolonged QTc interval (male \\>450ms, female \\>470ms), family history of sudden cardiac death \\\u003C40 years old\n7. GI perforation\u002Ffistula within 6 months, intestinal obstruction within 3 months (not fully resolved)\n8. Active severe bleeding disorder or active peptic ulcer disease\n9. Arterial\u002Fvenous thromboembolic event within past 6 months (stroke, DVT, pulmonary embolism etc.)\n10. Severe uncontrolled infection (≥CTCAE grade 2) within 4 weeks prior to first dose\n11. Active viral hepatitis (HBV DNA ≥2000 IU\u002FmL; active HCV viremia) or HIV positive\n12. History or active interstitial lung disease, pulmonary fibrosis, active tuberculosis\n13. Active autoimmune disease requiring long-term systemic immunosuppressive therapy\n14. Systemic corticosteroid dose \\>10 mg prednisone equivalent within 7 days pre-treatment\n15. Received live attenuated vaccine within 28 days before enrollment\n16. Hypersensitivity to any study drug or excipients\n17. Participation in other interventional clinical trials within 4 weeks prior to first dose\n18. Lactating female subjects\n19. Any medical, psychiatric or social condition judged by investigator to interfere with study compliance or subject safety","ALL","18 Years","75 Years",{"count":89,"type":90},80,"ESTIMATED","INTERVENTIONAL",[93],"PHASE2","This two-stage, multicenter, randomized open-label phase II trial enrolls untreated resectable stage II-III gastric\u002Fgastroesophageal junction adenocarcinoma patients with any HER2 expression. Stage 1 is a safety lead-in cohort of 6 patients receiving Trastuzumab Rezetecan(SHR-A1811)+Retlirafusp alfa(SHR-1701) plus CAPOX to assess dose-limiting toxicity (DLT) within 21 days after initial dosing. If safety risk is acceptable, stage 2 will randomize 74 eligible patients 1:1 into two parallel cohorts stratified by HER2 status. Cohort1 receives perioperative Trastuzumab Rezetecan(SHR-A1811)+Retlirafusp alfa(SHR-1701)+CAPOX; Cohort2 receives dual targeted-immunotherapy without chemotherapy (Trastuzumab Rezetecan+Retlirafusp alfa). All patients undergo D2 radical gastrectomy after neoadjuvant therapy, followed by adjuvant treatment and Retlirafusp alfa(SHR-1701) maintenance up to maximum 17 total cycles. The primary endpoint is pCR rate evaluated by CAP pathological criteria. Secondary endpoints include R0 resection rate, EFS, DFS, OS and perioperative\u002Fsurgical\u002Fsystemic safety profiles. Biomarker exploratory analysis will be performed to evaluate the correlation between PD-L1, MSI, TMB and clinical efficacy.",[96],"Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma","NOT_YET_RECRUITING","2026-09-02",{"date":100,"type":101},"2026-09-03","ACTUAL",{"date":103,"type":90},"2026-09-30",{"date":105,"type":90},"2031-09-30",{"name":5,"class":6},1]