[{"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":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":26,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":26,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":98,"whyStopped":26,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Dongguan People's Hospital","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"MRG003 + Toripalimab","EXPERIMENTAL","Participants receive 2 cycles of neoadjuvant combination therapy with toripalimab plus MRG003 (Becotatug vedotin). After the neoadjuvant phase, radical surgery is performed. Postoperative management follows the same risk-adapted criteria as the control arm: participants with ENE or positive\u002Finadequate margins receive adjuvant chemoradiotherapy, while those without receive adjuvant radiotherapy alone. During adjuvant radiotherapy, participants receive 3 cycles of concurrent toripalimab. After radiotherapy, all participants receive 12 cycles of adjuvant toripalimab maintenance therapy.",[13,14],"Drug: MRG003 (Becotatug vedotin) and Toripalimab","Drug: Toripalimab",{"label":16,"type":17,"description":18,"interventionNames":19},"Toripalimab Monotherapy","ACTIVE_COMPARATOR","Participants receive 2 cycles of neoadjuvant toripalimab monotherapy. After the neoadjuvant phase, radical surgery is performed. Postoperative management is determined by pathology: participants with extranodal extension (ENE) or positive\u002Finadequate margins receive adjuvant chemoradiotherapy (cisplatin 100 mg\u002Fm² every 3 weeks for 3 cycles plus radiotherapy at 60-70 Gy depending on risk), while those without receive adjuvant radiotherapy alone. During adjuvant radiotherapy, participants receive 3 cycles of concurrent toripalimab. After radiotherapy, all participants receive 12 cycles of adjuvant toripalimab maintenance therapy.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","MRG003 (Becotatug vedotin) and Toripalimab","Toripalimab 240 mg administered intravenously over 30-60 minutes on Day 1 of each 3-week cycle, followed immediately by MRG003 (Becotatug vedotin) 2.0 mg\u002Fkg (based on actual body weight) administered intravenously without prophylactic premedication. Neoadjuvant phase: 2 cycles of both drugs. Adjuvant toripalimab: 3 cycles concurrent with radiotherapy, then 12 cycles maintenance. For MRG003 (Becotatug vedotin), monitor infusion reactions for at least 120 minutes after first dose and at least 60 minutes after subsequent doses if tolerated. Dose reduction of MRG003 (Becotatug vedotin) to 1.5 mg\u002Fkg is permitted once for toxicity; permanent discontinuation if intolerance persists at reduced dose. Toripalimab dose remains fixed throughout; no dose modification is permitted.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Toripalimab","Toripalimab 240 mg administered intravenously over 30-60 minutes on Day 1 of each 3-week cycle. Neoadjuvant phase: 2 cycles. Adjuvant phase (concurrent with radiotherapy): 3 cycles. Adjuvant maintenance (after radiotherapy): 12 cycles. No prophylactic premedication required. No dose modification of toripalimab is permitted.",[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",[60,63,65,67,69,71,73],{"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",{"name":74,"class":62},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","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":86,"type":87},65,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","This is a multicenter, prospective, randomized, controlled Phase II trial evaluating the safety and efficacy of MRG003 (Becotatug vedotin) combined with Toripalimab versus Toripalimab alone as neoadjuvant therapy for PD-L1-positive, resectable locally advanced head and neck squamous cell carcinoma. A total of 65 subjects are planned (43 experimental, 22 control). The experimental arm receives two cycles of MRG003 (Becotatug vedotin) 2.0 mg\u002Fkg intravenously on Day 1 followed by Toripalimab 240 mg intravenously on Day 1 every 3 weeks, while the control arm receives two cycles of Toripalimab 240 mg alone. After neoadjuvant therapy, both arms undergo radical surgery 3-4 weeks later, followed by risk-adapted adjuvant radiotherapy or chemoradiotherapy with concurrent Toripalimab (3 cycles) and then 12 cycles of adjuvant Toripalimab maintenance. The primary endpoint is the major pathological response rate.",[93],"Head and Neck Squamous Cell Carcinoma",[95,96,28,97],"MRG003","Vebecototagene Autoleucovorin","Neoadjuvant Therapy","NOT_YET_RECRUITING","2026-08-04",{"date":101,"type":102},"2026-08-05","ACTUAL",{"date":104,"type":87},"2026-08-10",{"date":106,"type":87},"2029-06-30",{"name":5,"class":6},1]