Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Experimental arm:Surgical De-escalation After Neoadjuvant Therapy
Sponsors
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with stage III–IVa head and neck squamous cell carcinoma (HNSCC) according to the AJCC 8th edition TNM staging system, who have achieved a partial response (PR) or complete response (CR) after receiving neoadjuvant immunochemotherapy consisting of a PD-1 inhibitor in combination with nab-paclitaxel and carboplatin/cisplatin. 2.No prior history of other malignant tumors. 3.Aged between 18 and 75 years. 4.Normal baseline (preoperative) clinical and laboratory findings: (1)Absolute neutrophil count (ANC) >= 1.5 × 10?/L without the use of granulocyte colony-stimulating factor (G-CSF) within the previous 14 days (2)Platelet count >= 100 × 10?/L without blood transfusion within the previous 14 days (3)Hemoglobin > 9 g/dL without blood transfusion or erythropoietin use within the previous 14 days (4)Total bilirubin = 60 mL/min (7)Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 × ULN (8)Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Subjects with TSH outside the normal range may be included if total T3 (or FT3) and FT4 are within normal limits (9)Normal myocardial enzyme profile (minor laboratory abnormalities judged by the investigator to be clinically insignificant are acceptable) (10)Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose of study treatment (Cycle 1, Day 1). If the urine test is indeterminate, a serum test must be performed. Non-childbearing females are defined as those who have been postmenopausal for at least one year or have undergone surgical sterilization or hysterectomy. (11)All subjects (male or female) with reproductive potential must agree to use highly effective contraception (annual failure rate <1%) during treatment and for at least 120 days after the last dose of study drug, or 180 days after the last dose of chemotherapy. (12)Adverse events related to neoadjuvant therapy (e.g., bone marrow suppression, thyroiditis, hypothyroidism, hepatitis, nephritis, myocarditis, myositis, etc.) must have been adequately controlled and resolved to grade 0–2 before surgery. Patients assessed by anesthesiology as fit for general anesthesia may be included. (13)Patients with pre-existing comorbidities prior to neoadjuvant therapy may also be enrolled if evaluated by anesthesiology and deemed able to tolerate general anesthesia. 5.Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of another malignant tumor, or the primary lesion at the time of neoadjuvant therapy was not oral cancer. 2.Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to treatment. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment. 3.History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 4.Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV-1/2 antibody). 5.Untreated active hepatitis B infection, defined as HBsAg positivity with HBV-DNA levels exceeding the upper limit of normal (ULN) at the study site laboratory. Subjects meeting the following criteria may be enrolled: (1)HBV viral load =II) (2)Vascular diseases: history of unstable angina, myocardial infarction, transient ischemic attack, or stroke within 6 months prior to enrollment (3)Poorly controlled hypertension: systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg (4)Pulmonary diseases: noninfectious pneumonitis requiring corticosteroid treatment within 1 year before first dosing, or active interstitial lung disease (5)Infectious diseases: active infections requiring systemic therapy, or severe uncontrolled infections (6) Active pulmonary tuberculosis (7)Gastrointestinal diseases: clinically active diverticulitis, intra-abdominal abscess, or intestinal obstruction (8)Hepatic disorders: liver cirrhosis, decompensated liver disease, or acute/chronic active hepatitis (9)Uncontrolled diabetes mellitus: fasting blood glucose (FBG) > 10 mmol/L (10)Renal dysfunction: urine protein = ++ on routine urinalysis and 24-hour urinary protein > 1.0 g (11)Psychiatric disorders: severe mental illness that may affect treatment compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival;quality of life (QOL); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response;overall survival rate;Safety Endpoints; | — |
Countries
China
Contacts
Public ContactJinsong Li
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Outcome results
None listed