[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652007":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":30,"locations":39,"responsibleParty":70,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":29,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":29,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":101,"whyStopped":29,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant MRG003 + Pucotenlimab","EXPERIMENTAL","Participants receive 3 cycles of neoadjuvant Becotatug vedotin (MRG003) 2.3 mg\u002Fkg plus Pucotenlimab (HX008) 200 mg intravenously every 3 weeks, followed by radical surgery 2-3 weeks after the last neoadjuvant cycle. Postoperative adjuvant radiotherapy is stratified based on pathological response and risk factors.",[13,14],"Drug: Becotatug Vedotin (MRG003)","Drug: Pucotenlimab",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Becotatug Vedotin (MRG003)","Anti-EGFR antibody-drug conjugate (ADC) composed of a recombinant humanized anti-EGFR monoclonal antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable valine-citrulline linker. Administered at 2.3 mg\u002Fkg intravenously every 3 weeks for 3 cycles.",[9],[22],"MRG003",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Pucotenlimab","Humanized anti-PD-1 monoclonal antibody (IgG4) that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2. Administered at 200 mg intravenously every 3 weeks for 3 cycles.",[9],[28],"HX008",null,[31,36],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},"Yanping Mao","CONTACT","+86-13500019575","maoyp5@mail.sysu.edu.cn",{"name":37,"role":33,"phone":29,"phoneExt":29,"email":38},"Yanfeng Chen","chyanf@mail.sysu.edu.cn",[40,60],{"facility":41,"status":29,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hospital of Stomatology, Sun Yat-sen University","Guangzhou","Guangdong","510055","China","CN",{"type":48,"coordinates":49},"Point",[50,51],113.25,23.11667,{"lat":51,"lon":50},[54,58],{"name":55,"role":33,"phone":56,"phoneExt":29,"email":57},"Cheng Wang","+86-13760853366","wangch75@mail.sysu.edu.cn",{"name":55,"role":59,"phone":29,"phoneExt":29,"email":29},"PRINCIPAL_INVESTIGATOR",{"facility":61,"status":29,"city":42,"state":43,"zip":62,"country":45,"countryCode":46,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Sun Yat-sen University Cancer Center","510060",{"type":48,"coordinates":64},[50,51],{"lat":51,"lon":50},[67,68,69],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},{"name":37,"role":33,"phone":29,"phoneExt":29,"email":38},{"name":32,"role":59,"phone":29,"phoneExt":29,"email":29},{"type":59,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Mao Yanping","Mao Yanping, Professor, Department of Radiation Oncology, Sun Yat-sen University Cancer Center",[74],{"name":75,"class":76},"Lepu Biopharma Co., Ltd.","INDUSTRY","100652007","phase-2-neoadjuvant-presurgical-becotatug-vedotin-mrg003-plus-pucotenlimab-hx008-in-oral-cavity-squamous-cell-carcinoma-100652007",false,"NCT07766889","Neoadjuvant Presurgical Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Oral Cavity Squamous Cell Carcinoma","Neoadjuvant Presurgical Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Oral Cavity Squamous Cell Carcinoma：A Phase 2 Open-Label Clinical Trial","Inclusion Criteria:\n\n* Voluntary participation with written informed consent, good compliance, and willingness to complete follow-up.\n* Age ≥18 years and ≤70 years, regardless of gender.\n* ECOG performance status score of 0 or 1.\n* Histopathologically confirmed, previously untreated, primary oral cavity squamous cell carcinoma (OSCC); central laboratory-confirmed PD-L1 Combined Positive Score (CPS) ≥1; clinical stage III-IVA (AJCC 8th edition) with potential for curative surgical resection as assessed by the investigator; no evidence of definite locoregional residual or distant metastasis.\n* Adequate organ function within 14 days prior to the first dose, without transfusion or hematopoietic growth factor support:\n* Bone marrow: ANC ≥1.5×10\\^9\u002FL; platelet count ≥100×10\\^9\u002FL; hemoglobin ≥90 g\u002FL.\n* Liver: TBIL ≤1.5×ULN; AST\u002FALT ≤3.0×ULN; ALP ≤2.5×ULN; serum albumin ≥28 g\u002FL.\n* Kidney: creatinine clearance (Ccr) ≥40 mL\u002Fmin (calculated by Cockcroft-Gault formula) or serum creatinine ≤1.5×ULN.\n* Coagulation: INR ≤1.5×ULN and APTT ≤1.5×ULN (excluding patients receiving therapeutic anticoagulation).\n* Cardiac: LVEF ≥50% with no significant cardiac dysfunction.\n* Negative serum pregnancy test within 7 days prior to the first dose for women of childbearing potential; all fertile male and female participants must agree to use highly effective contraception from signing of informed consent through 1 year after the last dose of Pucotenlimab.\n\nExclusion Criteria:\n\n* Age \\>70 years or \\\u003C18 years.\n* History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n* HIV infection.\n* HBsAg positive with HBV DNA \\>200 IU\u002FmL or 1000 copies\u002FmL.\n* HCV antibody positive.\n* Severe concurrent diseases that may pose significant risks or affect trial compliance, including unstable cardiac disease, renal disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose \\>1.5×ULN), severe cognitive impairment, or psychiatric disorders.\n* Active pulmonary tuberculosis infection within the past 1 year, or history of active tuberculosis \\>1 year ago unless documented prior standard anti-tuberculosis treatment.\n* History of interstitial lung disease.\n* Active, known, or suspected autoimmune disease. Exceptions: type I diabetes, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia).\n* Systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressive therapy within 28 days prior to signing informed consent. Patients receiving ≤10 mg\u002Fday prednisone equivalent or inhaled\u002Ftopical corticosteroids are eligible.\n* Live vaccination within 30 days prior to signing informed consent or planned during the study.\n* Prior surgery, chemotherapy, radiotherapy, immunotherapy, or other anti-tumor therapy for head and neck cancer (excluding diagnostic procedures).\n* Known hypersensitivity to macromolecular protein preparations, or any component of Becotatug vedotin, Pucotenlimab, or cisplatin.\n* Pregnancy, lactation, or anticipated pregnancy during the study period.","ALL","18 Years","70 Years",{"count":88,"type":89},32,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","This is a phase 2, open-label, single-arm clinical trial evaluating neoadjuvant therapy with Becotatug vedotin (MRG003) combined with Pucotenlimab (HX008) in patients with previously untreated, resectable stage III-IVA oral cavity squamous cell carcinoma (OSCC) with a PD-L1 Combined Positive Score (CPS) of 1 or higher.\n\nEligible participants will receive 3 cycles of neoadjuvant treatment (Becotatug vedotin 2.3 mg\u002Fkg plus Pucotenlimab 200 mg, intravenously, every 3 weeks), followed by radical surgery 2-3 weeks after the last cycle of neoadjuvant therapy. Postoperative adjuvant radiotherapy will be stratified based on pathological response and risk factors: patients achieving major pathological response (MPR, defined as ≤10% residual viable tumor) with negative margins and no extranodal extension (ENE) will receive de-escalated radiotherapy (50-54 Gy); patients not achieving MPR or with high-risk features will receive standard radiotherapy (60-66 Gy) with or without concurrent cisplatin chemotherapy.\n\nThe primary endpoint is major pathological response (MPR). Secondary endpoints include objective response rate (ORR), pathological complete response (pCR), event-free survival (EFS), overall survival (OS), and safety profile. Exploratory biomarkers will be assessed in tumor tissue and peripheral blood.\n\nA total of 32-33 participants will be enrolled using a Simon two-stage optimal design (α=0.05, power=80%).",[95,96,97,98],"Oral Squamous Cell Carcinoma","Head and Neck Cancer","Locally Advanced Head and Neck Cancer","Neoadjuvant Therapy",[100],"MRG003, Becotatug vedotin, Pucotenlimab, anti-PD-1, ADC, EGFR, neoadjuvant therapy, oral squamous cell carcinoma, OSCC, head and neck cancer","NOT_YET_RECRUITING","2026-08-11",{"date":104,"type":105},"2026-08-17","ACTUAL",{"date":107,"type":89},"2026-09-01",{"date":109,"type":89},"2028-12-31",{"name":5,"class":6},2]