head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx)
Conditions
Interventions
Experimental group:Becotatug vedotin plus pucotenlimab neoadjuvant therapy, radical surgery, postoperative adjuvant radiotherapy or concurrent chemoradiotherapy, and Bec
Control group:Pucotenlimab neoadjuvant therapy, radical surgery, adjuvant radiotherapy or concurrent chemoradiotherapy, and Pucotenlimab adjuvant therapy.
Sponsors
Fifth Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign informed consent form; 2. Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx), EGFR-positive, CPS >= 1, with clinical stage (AJCC 8th edition): Oropharyngeal p16-positive: Stage III (T4 N0-2 M0); Oropharyngeal p16-negative: Stage III or IVA; Larynx/hypopharynx/oral cavity: Stage III or IVA. 3. Eligible for curative-intent surgery based on the surgeon’s assessment; 4. Age: 18 to 75 years; 5. ECOG performance status 0–1; 6. Life expectancy > 6 months; 7. At least one measurable lesion according to RECIST 1.1; 8. Adequate organ function, meeting all of the following criteria (without receipt of blood components or hematopoietic growth factors within 14 days prior to testing): Hemoglobin >= 90 g/L; Absolute neutrophil count >= 1.5 × 10?/L; Platelet count >= 100 × 10?/L; Serum albumin >= 28 g/L; Total bilirubin = 50 mL/min; Activated partial thromboplastin time and international normalized ratio (INR) = 50% as measured by multigated acquisition (MUGA) or echocardiography (ECHO); 10. Women of childbearing potential must agree to use contraceptive measures (e.g., intrauterine device, contraceptive pills, or condoms) during treatment and for 3 months after the last dose; 11. Good compliance.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; 2. History of hypersensitivity to PD-1 inhibitors; 3. History of other malignancies within the past 5 years or at study entry, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and thyroid papillary tumors. 4. Residual toxicities from prior anti-tumor therapy (including immunotherapy, targeted therapy, chemotherapy, or radiotherapy) (excluding alopecia, fatigue, and grade 2 hypothyroidism) or clinically significant laboratory abnormalities > grade 1 (CTCAE v5.0); 5. Uncontrolled cardiac clinical symptoms or diseases, such as: a. New York Heart Association (NYHA) class II or higher heart failure; b. unstable angina; c. myocardial infarction within 1 year; and d. clinically significant ventricular or supraventricular arrhythmias requiring intervention. 6. Peripheral neuropathy >= grade 2 (CTCAE v5.0); 7. Pulmonary embolism or deep vein thrombosis (excluding catheter-related thrombosis from a port or PICC line) within 3 months prior to enrollment. 8. Active bleeding, history of coagulation disorders, or receiving coumarin anticoagulant therapy. 9. Known hypersensitivity to any component or excipient of Becotatug vedotin (citric acid monohydrate, sodium citrate dihydrate, trehalose dihydrate, sodium chloride, and polysorbate 80), or known grade >= 3 hypersensitivity to other prior anti-EGFR agents (including investigational drugs) or to other monoclonal antibodies. 10. Receipt of any of the following treatments: a. Any investigational drug prior to the first dose of current study drug. b. Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study or during follow-up. c. Requirement for systemic treatment with corticosteroids (>10 mg prednisone or equivalent per day) or other immunosuppressive agents within 2 weeks prior to the first dose of study drug, except for the use of corticosteroids for local inflammation, prevention of allergy, or nausea/vomiting. Inhaled or topical steroids and adrenal replacement steroid doses >10 mg prednisone equivalent per day are permitted in the absence of active autoimmune disease. d. Receipt of live vaccine within 4 weeks prior to the first dose of study drug. e. Major surgery or severe trauma within 4 weeks prior to the first dose of study drug. 11. Serious infection (> grade 2 according to CTCAE), such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications occurring within 4 weeks prior to the first dose of study drug; baseline chest imaging showing active pulmonary inflammation or infection symptoms/signs within 2 weeks prior to the first dose of study drug, or indicating need for oral or intravenous antibiotics (excluding prophylactic antibiotics). 12. Prior or concurrent history of severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, symptomatic bronchospasm, etc. 13. History of active autoimmune diseases and syndromes (including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism). Patients with vitiligo that does not require any intervention in adulthood or cured childhood asthma/atopy are not excluded. 14. History of immunodeficiency, including HIV-positive status or other acquired/congenital immunodeficiency diseases, or history of organ transplantation or bone marrow transplantation. 15. Active tuberculosi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year event-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of treatment-related adverse events;Disease Control Rate;Non Surgical Delay Rate;Quality of Life Assessment;R0 Resection Rate;Objective Response Rate;3-year overall survival rate;3-Year Distant Metastasis Free Survival;Pathologic Complete Response Rate;The percentage of participants in a clinical trial who are alive and free from local and/or regional tumor recurrence 3 years after randomization.;Major Pathological Response Rate; | — |
Countries
China
Contacts
Public ContactChen Mingyuan
Fifth Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed