[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644941":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":56,"collaborators":58,"id":72,"slug":26,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":26,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":94,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"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,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Dongguan","Guangdong","523059","China",{"type":49,"coordinates":50},"Point",[51,52],113.74866,23.01797,{"lat":52,"lon":51},[55],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[59,62,64,66,68,70],{"name":60,"class":61},"Sun Yat-Sen University Cancer Center","OTHER",{"name":63,"class":61},"Shenzhen People's Hospital",{"name":65,"class":61},"Peking University Shenzhen Hospital",{"name":67,"class":61},"The University of Hong Kong-Shenzhen Hospital",{"name":69,"class":61},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"name":71,"class":61},"Huizhou Municipal Central Hospital","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":82,"type":83},65,"ESTIMATED","INTERVENTIONAL",[86],"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.",[89],"Head and Neck Squamous Cell Carcinoma",[91,92,28,93],"MRG003","Vebecototagene Autoleucovorin","Neoadjuvant Therapy","NOT_YET_RECRUITING","2026-06-28",{"date":97,"type":98},"2026-06-30","ACTUAL",{"date":97,"type":83},{"date":101,"type":83},"2029-06-30",{"name":5,"class":6},1]