[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-ivb-oral-cavity-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-ivb-oral-cavity-squamous-cell-carcinoma":27},{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100657915","phase-2-immunoadc-therapy-for-induction-conversion-in-patients-with-stage-ivb-osccopscc-100657915",false,"NCT07844551","ImmunoADC Therapy for Induction Conversion in Patients With Stage IVB OSCC\u002FOPSCC","Immunotherapy Combined With ADC (MRG003) for Induction Conversion Therapy to Downstage Primary Stage IVB Oral\u002FOropharyngeal Squamous Cell Carcinoma：An Exploratory Two-Arm Randomized Controlled Trial (Transforming Trial)","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;\n2. Histopathologically confirmed oral\u002Foropharyngeal squamous cell carcinoma, including tumors of the tongue, gingiva, buccal mucosa, floor of mouth, hard palate, retromolar trigone, base of tongue, soft palate, or parapharyngeal region;\n3. Clinical stage IVB (cT1-4N3M0 or cT4bN0-3M0, AJCC 8th edition);\n4. At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;\n5. Complete blood count: white blood cell count \\>3,000\u002Fmm3, hemoglobin \\>8 g\u002FL, and platelet count \\>80,000\u002Fmm3;\n6. Hepatic function: alanine aminotransferase\u002Faspartate aminotransferase (ALT\u002FAST) \\\u003C2.5 times the upper limit of normal (ULN), and bilirubin \\\u003C1.5 times the ULN;\n7. Renal function: serum creatinine \\\u003C1.5 times the ULN;\n8. Positive PD-L1 expression (combined positive score \\[CPS\\] \\>=1) and positive EGFR expression (immunohistochemistry \\[IHC\\] 2+ or 3+);\n9. Written informed consent provided.\n\nExclusion Criteria:\n\n1. Unresolved toxicity of grade 2 or higher due to prior anticancer therapy;\n2. Known grade 3-4 hypersensitivity reaction to any study treatment;\n3. Active severe clinical infection (\\>grade 2 infection according to NCI-CTCAE version 5.0);\n4. Uncontrolled hypertension or active cardiovascular disease, including cerebrovascular accident within 6 months before randomization, myocardial infarction within 6 months before randomization, unstable angina, congestive heart failure of New York Heart Association (NYHA; Appendix 5) class II or higher, or a serious arrhythmia that cannot be controlled with medication or may potentially affect study treatment;\n5. Active autoimmune disease requiring systemic immunomodulatory or corticosteroid therapy for a chronic condition (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants). Replacement therapy, such as thyroxine, insulin, or physiologic glucocorticoid replacement for adrenal or pituitary insufficiency, is not considered systemic therapy;\n6. History of another malignancy and its treatment;\n7. History of radiotherapy to the maxillofacial and neck region;\n8. HPV-positive oropharyngeal cancer;\n9. Pregnant or breastfeeding women;\n10. Known history of human immunodeficiency virus (HIV) infection, or uncontrolled active hepatitis B, defined as hepatitis B surface antigen (HBsAg) positivity together with a detectable hepatitis B virus DNA (HBV-DNA) copy number above the upper limit of normal of the local laboratory at the study center;\n11. Participation in another clinical study within 30 days before enrollment;\n12. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.","ALL","18 Years","80 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","To evaluate the efficacy and safety of Becotatug Vedotin (EGFR-targeted ADC, MRG003) plus Pucotenlimab (PD-1 inhibitor), compared with platinum-based chemotherapy\u002Fchemoradiotherapy, as an induction conversion regimen for downstaging primary stage IVB oral squamous cell carcinoma or HPV16-negative oropharyngeal squamous cell carcinoma.",[27,28],"Stage IVB Oral Cavity Squamous Cell Carcinoma","Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8",[30,31,32],"Combination of immunotherapy and antibody-drug conjugate","Stage IVB OSCC or OPSCC","Induction conversion","NOT_YET_RECRUITING","2026-09-22",{"date":36,"type":37},"2026-09-28","ACTUAL",{"date":39,"type":21},"2026-10-20",{"date":41,"type":21},"2030-12-30",{"name":43,"class":44},"Huashan Hospital","OTHER"]