Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Eexperimental group:Sacituzumab Tirumotecan 5 mg/kg is administered by intravenous infusion once every 3 weeks, and Tagitanlimab injection 1,200 mg is given by intravenous infusion once every 3 weeks,
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old at the time of signing the informed consent form, regardless of gender; 2. Pathologically or cytologically confirmed locally advanced head and neck squamous cell carcinoma (including squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, etc.) and deemed resectable by a surgeon; 3. No prior systemic therapy for head and neck squamous cell carcinoma; 4. Assessed as resectable by the investigator and willing to receive radical surgery; 5. Presence of at least one measurable lesion (per RECIST 1.1 criteria); 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 7. No contraindications to surgery; 8. Sufficient organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin or colony-stimulating factor therapy administered within 2 weeks prior to the first dose), defined as follows: (1) Hematology: Absolute neutrophil count (NEUT#) >= 1.5 × 10?/L; Platelet count (PLT) >= 100 × 10?/L; Hemoglobin >= 90 g/L; (2) Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 30 g/L; Total bilirubin (TBIL) = 50 ml/min (calculated using the standard Cockcroft-Gault formula); (4) Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT) and prothrombin time (PT) <= 1.5 × ULN; 9. Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must agree to adopt effective medical contraceptive measures from the time of signing the informed consent form until 6 months after the last dose; 10. Subjects voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Participation in other clinical trials of medicinal products within 4 weeks prior to enrollment. 2. Previous receipt of anticancer therapy for head and neck tumors. 3. History of other malignant tumors within the past 5 years, excluding curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or cutaneous squamous cell carcinoma. 4. Known history of hypersensitivity to the study drugs (tragolimab/lucamzumab) and their components. 5. Positive human immunodeficiency virus (HIV) test result or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. 6. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 7. Vaccination with live vaccines within 30 days prior to the first administration of the study drug. 8. History of non-infectious interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid therapy; current presence of ILD or non-infectious pneumonia; or suspected ILD or non-infectious pneumonia at screening that cannot be ruled out by imaging examinations. Clinically significant pulmonary impairment due to concurrent pulmonary diseases, including but not limited to any underlying pulmonary conditions (e.g., pulmonary embolism within 3 months prior to administration, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory diseases that may involve the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior pneumonectomy. 9. History of active autoimmune diseases requiring systemic therapy within the past 2 years (hormone replacement therapy is not considered systemic therapy, such as type 1 diabetes mellitus, hypothyroidism requiring only levothyroxine replacement therapy, and adrenal or pituitary insufficiency requiring only physiological doses of glucocorticoid replacement therapy). 10. Active infections requiring systemic treatment within 2 weeks prior to the first administration of the study drug. 11. According to the investigator's judgment, presence of concurrent diseases that seriously endanger the patient's safety or affect the patient's completion of the study, including but not limited to uncontrolled hypertension, severe diabetes mellitus, active infections, etc. 12. Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal diseases that hinder or delay corneal wound healing. 13.Pregnant or lactating female patients; female patients of childbearing potential with a positive baseline pregnancy test; female patients of childbearing potential who are unwilling to adopt effective contraceptive; 14. Any other conditions deemed by the investigator to make the patient unsuitable for participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response (pCR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event?free survival (EFS);Saftey;Major Pathologic Response (MPR) rate;Overall survival (OS);Objective response rate (ORR);Adverse events (AEs); | — |
Countries
China
Contacts
Public ContactXingguang Han
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed