squamous cell carcinoma of the head and neck
Conditions
Interventions
Test group :After treatment with combination therapy of sintilimab and chemotherapy, surgery is performed, and postoperative radiotherapy plus sintilimab maintenance or sintilimab maintenance is used
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form and understand and agree to follow the study requirements and the study visit schedule. 2. Male or female subjects aged =18 and =75 years at the time of signing the informed consent form. 3. Patients with resectable locally advanced squamous cell carcinoma of the head and neck mucosa, including oral cancer, oropharyngeal cancer (p16 positive and p16 negative), nasal cavity cancer, paranasal sinus cancer, laryngeal cancer, hypopharyngeal cancer, cervical tracheal cancer, and cervical esophageal cancer, confirmed by histology or cytology, at first diagnosis or after surgical recurrence. 4. Inclusion stage: III-IV, specifically including stage III, stage IVA, and some stage IVB, excluding cases such as T4b that are not suitable for radical surgery. 5. Evaluated by a multidisciplinary team as suitable for surgery and willing to undergo radical surgery. 6. According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), there is at least one measurable lesion by imaging. 7. ECOG PS score of 0-1. 8. Expected survival time > 3 months. 9. No previous systemic treatment for head and neck squamous cell carcinoma (including chemotherapy, EGFR monoclonal antibodies, anti-PD-1 or anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.). 10. Adequate organ function, subjects must meet the following laboratory indicators: 1) Absolute neutrophil count (ANC) >= 1.5x10^9/L within 14 days without granulocyte colony-stimulating factor. 2) Platelet count >= 100×10^9/L within 14 days without blood transfusion. 3) Hemoglobin > 9g/dL within 14 days without blood transfusion or erythropoietin. 4) Total bilirubin = 60 ml/min. 7) Good 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 normal range. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within normal range can also be included. 9) Normal myocardial enzymes (if the researcher comprehensively determines that the abnormality is not clinically significant, it is also allowed to be included). 11. For female subjects of childbearing age, a urine or serum pregnancy test must be negative within 3 days before the first administration of the study drug (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing age females are defined as those who have been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy. 12. If there is a risk of pregnancy, all subjects (regardless of gender) must use a contraceptive method with a failure rate of less than 1% per year throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy drugs).
Exclusion criteria
Exclusion criteria: 1. Diagnosis of any malignant disease other than head and neck squamous cell carcinoma within 3 years prior to the first dose (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or carcinoma in situ that has been treated with radical resection); 2. Confirmed distant metastasis by clinical or imaging examination; 3. Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose; 4. Previous treatment with the following therapies: chemotherapy, radiotherapy, and anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or drugs targeting another T-cell receptor stimulator or co-inhibitor (e.g., CTLA-4, OX-40, CD137); 5. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (e.g., thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment; 6. Systemic glucocorticoid treatment within 7 days prior to the first dose of the study (excluding nasal spray, inhalation, or other local glucocorticoids) or any other form of immunosuppressive therapy; Note: Physiological doses of glucocorticoids (<=10mg/day of prednisone or equivalent) are allowed; 7. Known hypersensitivity to the study drug sintilimab or its excipients; 8. Known hypersensitivity to the study chemotherapy drugs or their excipients; 9. Pregnant or lactating women; 10. The investigator assesses that there is any severe or uncontrolled systemic disease; 11. Any history or evidence of disease, treatment, or abnormal laboratory values that may interfere with the trial results, prevent the subject from fully participating in the study, or the investigator deems other unsuitable conditions for inclusion. The investigator deems that there are other potential risks that make the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year Disease-Free Survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease control rate;Pathological Complete Response; | — |
Countries
China
Contacts
Public ContactGuo Liang
Zhejiang Cancer Hospital
Outcome results
None listed