[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xuekui Liu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100655529","phase-2-becotatug-vedotin-plus-pucotenlimab-and-platinum-chemotherapy-in-locally-advanced-epidermal-growth-factor-receptor-egfr-positive-head-and-neck-squamous-cell-carcinoma-100655529",false,"NCT07814287","Becotatug Vedotin Plus Pucotenlimab and Platinum Chemotherapy in Locally Advanced Epidermal Growth Factor Receptor (EGFR)-Positive Head and Neck Squamous Cell Carcinoma","Becotatug Vedotin Plus Pucotenlimab and Platinum Chemotherapy in Locally Advanced Epidermal Growth Factor Receptor (EGFR)-Positive Head and Neck Squamous Cell Carcinoma: A Phase II Prospective Single-Arm Multicenter Trial","Inclusion Criteria:\n\nHistologically and\u002For cytologically confirmed, previously untreated (excluding diagnostic procedures) head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx) with EGFR protein expression confirmed by immunohistochemistry (IHC), and has not received targeted therapy against the EGFR signaling pathway within 6 months prior to enrollment.\n\nClinical stage T2N2-3M0 or T3-4N0-3M0 (stage III-IV) per AJCC 8th edition.\n\nAge 18 to 70 years.\n\nECOG performance status 0 or 1.\n\nAssessed by head and neck oncologist as locally advanced without distant metastasis.\n\nAt least one measurable lesion per RECIST v1.1.\n\nToxicity assessment per CTCAE v4.03 (for baseline evaluation).\n\nAdequate organ function to tolerate surgery:\n\nHematologic: WBC ≥4,000\u002FμL, ANC ≥2,000\u002FμL, hemoglobin ≥9 g\u002FdL, platelets ≥100,000\u002FμL.\n\nHepatic: bilirubin ≤1.5×ULN (or ≤3×ULN if known Gilbert's syndrome), AST and ALT ≤3×ULN, alkaline phosphatase ≤3×ULN, albumin ≥3 g\u002FdL.\n\nRenal: serum creatinine ≤1.5×ULN or calculated creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault).\n\nWilling to provide archived tumor tissue or undergo biopsy to submit at least 3 unstained FFPE sections (additional if needed) for central PD-L1 IHC testing; lesion used for biopsy cannot be a target lesion unless no other suitable lesion exists.\n\nSigned informed consent and willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\nHistory of severe hypersensitivity to any component of other monoclonal antibodies, CTLA-4, or PD-1\u002FPD-L1 inhibitors.\n\nKnown or suspected autoimmune disease, including dementia and seizure disorder.\n\nRecurrent or metastatic disease, concurrent other malignancy, or judged inoperable by head and neck surgeon.\n\nCoagulation abnormalities (PT \\>16 s, APTT \\>53 s, TT \\>21 s, Fib \\\u003C1.5 g\u002FL), bleeding tendency, or current thrombolytic\u002Fanticoagulant therapy.\n\nSevere cardiac or pulmonary dysfunction less than grade 3 (including grade 3).\n\nLaboratory values not meeting eligibility criteria within 7 days prior to enrollment.\n\nPrior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other agents targeting T-cell co-stimulation or checkpoint pathways).\n\nComorbid conditions requiring chronic immunosuppressive therapy or systemic\u002Flocal corticosteroids at immunosuppressive doses.\n\nPositive HIV; HBsAg-positive with detectable HBV DNA (≥1000 copies\u002FmL); positive HCV antibody with detectable HCV RNA (if tested).\n\nUse of traditional herbal medicines with antitumor indications within 4 weeks prior to randomization.\n\nActive or history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, chronic diarrhea).\n\nPositive pregnancy test (for women of childbearing potential) or breastfeeding.\n\nKnown active tuberculosis (TB); suspected cases require clinical evaluation to rule out.\n\nHistory of allogeneic organ or hematopoietic stem cell transplantation.\n\nSevere infection within 4 weeks prior to first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia.\n\nPlanned major surgery within 30 days after first dose (or not fully recovered from prior surgery), except for minor procedures (e.g., port placement, biopsy) if performed at least 24 hours before first dose.","ALL","18 Years","70 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This prospective, single-arm, multicenter phase II trial aims to evaluate the efficacy and safety of neoadjuvant beccotatug vedotin combined with pucotenlimab and cisplatin in patients with locally advanced epidermal growth factor receptor (EGFR)-positive head and neck squamous cell carcinoma (HNSCC). A total of 40 treatment-naive patients aged 18-70 years with stage III-IV (AJCC 8th edition) EGFR-positive HNSCC will be enrolled. Participants will receive three 3-week cycles of the triple-drug regimen. Tumor response will be reassessed after cycle 3 using RECIST v1.1. Patients achieving a complete or partial response (CR\u002FPR) may proceed to de-escalation surgery followed by definitive chemoradiotherapy, or to definitive chemoradiotherapy alone; non-responders will undergo radical surgery with or without radiotherapy\u002Fchemoradiotherapy, or definitive chemoradiotherapy, as determined by multidisciplinary team (MDT) discussion. The primary endpoint is objective response rate (ORR). Secondary endpoints include major pathological response (MPR), pathological complete response (pCR), disease control rate (DCR), 2-year progression-free survival (PFS), 2-year overall survival (OS), quality of life, and safety.\n\nThis study aims to provide preliminary evidence on the feasibility and activity of this novel triple combination in the neoadjuvant setting, potentially offering a new treatment paradigm to improve long-term outcomes and reduce recurrence.",[27],"Head and Neck Squamous Cell Carcinoma, HNSCC",[29,30,31],"antibody-drug conjugate","Head and neck squamous cell carcinoma, HNSCC","Neoadjuvant combination therapy","RECRUITING","2026-09-09",{"date":35,"type":36},"2026-09-10","ACTUAL",{"date":38,"type":36},"2026-04-15",{"date":40,"type":21},"2028-12-31",{"name":42,"class":43},"Xuekui Liu","OTHER",2,""]