[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644941":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":57,"collaborators":59,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":26,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":26,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":96,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Dongguan People's Hospital","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"MRG003 + Toripalimab","EXPERIMENTAL","Two cycles of neoadjuvant MRG003 (Vebecototagene Autoteucovaline) 2.0 mg\u002Fkg intravenous infusion on Day 1 plus Toripalimab 240 mg intravenous infusion on Day 1 of each 21-day cycle, followed by radical surgery and risk-adapted adjuvant therapy (radiotherapy ± concurrent cisplatin + Toripalimab maintenance up to 12 cycles).",[13,14],"Drug: MRG003 and Toripalimab","Drug: Toripalimab",{"label":16,"type":17,"description":18,"interventionNames":19},"Toripalimab Monotherapy","ACTIVE_COMPARATOR","Two cycles of neoadjuvant Toripalimab 240 mg intravenous infusion on Day 1 of each 21-day cycle (monotherapy), followed by radical surgery and risk-adapted adjuvant therapy (radiotherapy ± concurrent cisplatin + Toripalimab maintenance up to 12 cycles). During adjuvant radiotherapy, 3 cycles of concurrent Toripalimab 240 mg Q3W are given.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","MRG003 and Toripalimab","Neoadjuvant MRG003 (2.0 mg\u002Fkg IV Q3W) plus Toripalimab (240 mg IV Q3W for 2 cycles), followed by radical surgery and risk-adapted adjuvant therapy.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Toripalimab","Neoadjuvant Toripalimab (240 mg IV Q3W for 2 cycles), followed by radical surgery and risk-adapted adjuvant therapy.",[9,16],[32],{"name":33,"affiliation":34,"role":35},"Zhigang Liu, MD","The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital)","STUDY_CHAIR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Liji Jiang, Master","CONTACT","0769-28637916","keynotejiang@163.com",[43],{"facility":34,"status":26,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Dongguan","Guangdong","523059","China","CN",{"type":50,"coordinates":51},"Point",[52,53],113.74866,23.01797,{"lat":53,"lon":52},[56],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[60,63,65,67,69,71],{"name":61,"class":62},"Sun Yat-Sen University Cancer Center","OTHER",{"name":64,"class":62},"Shenzhen People's Hospital",{"name":66,"class":62},"Peking University Shenzhen Hospital",{"name":68,"class":62},"The University of Hong Kong-Shenzhen Hospital",{"name":70,"class":62},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"name":72,"class":62},"Huizhou Municipal Central Hospital","100644941","phase-2-mrg003-plus-toripalimab-versus-toripalimab-as-neoadjuvant-therapy-for-pd-l1-positive-resectable-locally-advanced-head-and-neck-squamous-cell-carcinoma-100644941",false,"NCT07677475","MRG003 Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma","MRG003 (Becotatug Vedotin) Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma: A Multicenter, Prospective, Randomized, Controlled Phase II Trial","1. Histologically or cytologically confirmed head and neck squamous cell carcinoma (HNSCC), PD-L1 positive (CPS ≥ 1)\n2. Treatment-naïve, pathologically confirmed stage III-IVA resectable non-oropharyngeal HNSCC (oral cavity, larynx, hypopharynx) OR HPV-negative oropharyngeal SCC, OR HPV-positive stage III T4N0-2 resectable oropharyngeal cancer (AJCC 8th edition)\n3. No prior antitumor treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy)\n4. Age 18 to 70 years\n5. ECOG performance status 0 or 1\n6. Adequate organ function within 14 days before first dose (no blood products or growth factors within 14 days):\n\n   * ANC ≥ 1.0 × 10⁹\u002FL, Hb ≥ 90 g\u002FL, PLT ≥ 75 × 10⁹\u002FL\n   * ALT\u002FAST ≤ 1.5 × ULN, total bilirubin ≤ 1.5 × ULN, ALP \\\u003C 2.5 × ULN\n   * CrCl ≥ 50 mL\u002Fmin (Cockcroft-Gault)\n   * APTT and INR ≤ 1.5 × ULN\n7. At least one measurable lesion per RECIST 1.1\n8. Life expectancy ≥ 12 weeks\n9. Female subjects of childbearing potential and male subjects with reproductive potential must use medically accepted contraception during treatment and for 3 months after last dose\n10. Voluntary signed informed consent, good compliance, willing to undergo follow-up","ALL","18 Years","70 Years",{"count":84,"type":85},65,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","This is a multicenter, randomized, open-label, controlled Phase 2 trial evaluating neoadjuvant MRG003 (anti-EGFR ADC) plus toripalimab versus toripalimab alone in PD-L1-positive (CPS ≥ 1), resectable, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Patients are randomized 2:1 to receive 2 cycles of MRG003 2.0 mg\u002Fkg IV plus toripalimab 240 mg IV Q3W (n=43) or toripalimab 240 mg IV Q3W alone (n=22), followed by surgery and risk-adapted adjuvant therapy including radiotherapy and toripalimab maintenance. The primary endpoint is Major Pathological Response (MPR) rate. Secondary endpoints include pCR, ORR, EFS, R0 resection rate, surgical down-staging, and safety. Enrolling 65 participants across 11 centers in China.",[91],"Head and Neck Squamous Cell Carcinoma",[93,94,28,95],"MRG003","Vebecototagene Autoleucovorin","Neoadjuvant Therapy","NOT_YET_RECRUITING","2026-06-28",{"date":99,"type":100},"2026-06-30","ACTUAL",{"date":99,"type":85},{"date":103,"type":85},"2029-06-30",{"name":5,"class":6},1]