[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657915":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":31,"studyPopulation":24,"armGroups":32,"interventions":46,"overallOfficials":60,"centralContacts":64,"locations":24,"responsibleParty":75,"collaborators":24,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":24,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":24,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":101,"whyStopped":24,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":24},{"fullName":5,"class":6},"Huashan Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical downstaging rate","The ratio of patients could achieve clinical downstaging after two cycles of drug treatment according to the AJCC 8th edition.","6 months",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Surgical R0 resection rate","The ratio of R0 resection, complete removal of all grossly visible tumor with no residual tumor cells at the microscopic resection margins, i.e., microscopically negative margins.",{"measure":18,"description":19,"timeFrame":20},"Rate of 2-year overall survival","Overall survival is calculated from the date of randomization to death. The rate of 2-year overall survival is reported as the percentage of patients who are overall survival for 2 years from the date of randomization.","2 years",{"measure":22,"description":23,"timeFrame":20},"Rate of 2-year progression free survival","Progression free survival is calculated from the date of randomization to local tumor recurrence or progression, locoregional recurrence or progression, distant metastasis, or death. The rate of 2-year progression free survival is reported as the percentage of patients who are progression free survival for 2 years from the date of randomization.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE","More than 60% of patients with head and neck squamous cell carcinoma (HNSCC) have locally advanced disease at initial diagnosis, often presenting with a large primary tumor accompanied by marked local invasion and\u002For regional lymph-node metastasis. In patients with clinical stage IVB oral squamous cell carcinoma (OSCC), tumors frequently invade the masticator space, pterygoid plates, or skull base and\u002For encase the internal carotid artery; and in patients with clinical stage IVB oropharyngeal squamous cell carcinoma (OPSCC), tumors frequently invade the lateral pterygoid muscle, pterygoid plates, lateral nasopharyngeal wall, or skull base, or encase the carotid artery. Because of extensive infiltration and involvement of critical anatomical structures, radical surgery faces two major challenges in this population: firstly, R0 resection is difficult to achieve, resulting in rapid postoperative recurrence; secondly, radical surgery inevitably causes disfiguring tissue defects and severe functional loss, leading to extremely poor quality of life. The 1- to 2-year overall survival rate for these patients ranges from 22% to 35%.\n\nFor the patients with unresectable primary stage IVB OSCC or human papillomavirus (HPV)-negative OPSCC, current standard treatment consists of platinum-based concurrent chemoradiotherapy or radiotherapy following platinum-based induction chemotherapy. Although these regimens are widely used, their efficacy remains unsatisfactory. In recent years, additional approaches have been developed and evaluated, including monoclonal antibodies targeting epidermal growth factor receptor (EGFR), novel radiotherapy fractionation schedules, and induction or neoadjuvant chemotherapy regimens; however, none has demonstrated a clear improvement over standard concurrent chemoradiotherapy. Standard concurrent chemoradiotherapy may also cause toxicities such as late-onset dysphagia and severe xerostomia. Accordingly, developing new therapeutic strategies to improve outcomes in this population has become a major focus in the field of HNSCC.\n\nNeoadjuvant therapy refers to antitumor treatment administered before surgery with the aims of reducing tumor volume, increasing the likelihood of surgical resection, and decreasing the risk of postoperative recurrence; it may therefore improve outcomes in locally advanced malignancies. Given the close interaction between antibody-drug conjugate (ADC) and the host immune system, the combination of these two modalities may theoretically produce synergistic antitumor effects and improve treatment outcomes. Therefore, this prospective, exploratory, two-arm, randomized controlled clinical trial will compare becotatug vedotin, an EGFR-targeted ADC, plus pucotenlimab, an anti-PD-1 monoclonal antibody, with current standard therapy consisting of platinum-based induction chemotherapy or chemoradiotherapy. The investigational regimen is expected to induce deep tumor regression in patients with unresectable primary stage IVB OSCC\u002FOPSCC, achieve tumor downstaging, convert unresectable lesions into lesions amenable to R0 resection, and allow evaluation of efficacy and safety, including potential survival benefits. The study may provide a new therapeutic strategy for patients with stage IVB HNSCC.",[33,40],{"label":34,"type":35,"description":36,"interventionNames":37},"Experimental Arm","EXPERIMENTAL","Combination therapy of immunotherapy and antibody-drug conjugate. Drugs: Becotatug vedotin: 2.3 mg\u002Fkg by intravenous infusion once every 21 days. Pucotenlimab: 200 mg by intravenous infusion once every 21 days.\n\nEach treatment cycle is 21 days, and two cycles will be administered. On each dosing day, pucotenlimab will be infused first, followed by becotatug vedotin.",[38,39],"Drug: Becotatug Vedotin (MRG003)","Drug: Pucotenlimab",{"label":41,"type":42,"description":43,"interventionNames":44},"Control Arm","ACTIVE_COMPARATOR","Participants in the control arm will undergo MDT assessment by the investigators and receive a platinum-based induction chemotherapy regimen. Cisplatin: 75mg\u002Fm2 by intravenous infusion once every 21 days. Each treatment cycle is 21 days, and two cycles will be administered. All required assessments must be completed within 3 days before dosing. Treatment may continue only after the safety evaluation is satisfactory.",[45],"Drug: Cisplatin",[47,52,56],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":24},"DRUG","Becotatug Vedotin (MRG003)","2.3 mg\u002Fkg by intravenous infusion once every 21 days",[34],{"type":48,"name":53,"description":54,"armGroupLabels":55,"otherNames":24},"Pucotenlimab","200 mg by intravenous infusion once every 21 days",[34],{"type":48,"name":57,"description":58,"armGroupLabels":59,"otherNames":24},"Cisplatin","75mg\u002Fm2 by intravenous infusion once every 21 days",[41],[61],{"name":62,"affiliation":5,"role":63},"Lai-ping Zhong","PRINCIPAL_INVESTIGATOR",[65,70],{"name":66,"role":67,"phone":68,"phoneExt":24,"email":69},"Lai-ping Zhong, MD, PhD","CONTACT","+862152888915","zhonglp@hotmail.com",{"name":71,"role":67,"phone":72,"phoneExt":73,"email":74},"Ying-ying Huang, MD, PhD","+862152889999","7182","kqyxyhyy@163.com",{"type":63,"investigatorFullName":62,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Professor","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":88,"type":89},40,"ESTIMATED","INTERVENTIONAL",[92],"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.",[95,96],"Stage IVB Oral Cavity Squamous Cell Carcinoma","Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8",[98,99,100],"Combination of immunotherapy and antibody-drug conjugate","Stage IVB OSCC or OPSCC","Induction conversion","NOT_YET_RECRUITING","2026-09-22",{"date":104,"type":105},"2026-09-28","ACTUAL",{"date":107,"type":89},"2026-10-20",{"date":109,"type":89},"2030-12-30",{"name":5,"class":6}]