Locally advanced head and neck squamous cell carcinoma
Conditions
Interventions
observation group:Sindillizumab :200mg, i.v., d1, q3w
Cisplatin 25 mg/m2, i.v.,d1-3,q3w Paclitaxel 75 mg/m2, i.v.,d1,q3w, Radical head and neck squamous cell carcinoma resection was evaluated by the investigators at 3-4 weeks after the completion of th
Sponsors
Affiliated Hospital of Yanbian University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Provided written informed consent before performing any trial-related procedures; 2. Male or female >=18 years old, and 6 months; 9. Adequate organ function, subject must meet the following laboratory indicators: 1) absolute neutrophil count (ANC) >=1.5x109/L without using granulocyte colony-stimulating factor for the past 14 days. 2) platelet count >=100×10^9/L without blood transfusion in the past 14 days. 3) hemoglobin >9g/dL in the absence of blood transfusion or erythropoietin use in the past 14 days; 4) Total bilirubin =60 ml/min; 7) good coagulation function, defined as INR or PT <=1.5 times ULN; 8) Euthyroid, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH was beyond the normal range, the subjects could be included if the total T3 (or FT3) and FT4 were within the normal range. 9) Myocardial enzymes within the normal range (simple laboratory abnormalities that were judged by the investigators as not clinically significant were also allowed); 10. For women of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days before receiving the first dose of study drug (day 1 of cycle 1). If a urine pregnancy test result could not be confirmed as negative, a blood pregnancy test was requested. Women who were not of reproductive age were defined as those who had been postmenopausal for at least 1 year or had undergone surgical sterilization or hysterectomy. If there was a risk of pregnancy, all participants (male or female) were required to use contraception with an annualized failure rate of less than 1% for the entire treatment period until 120 days after the last dose of study drug on treatment (or 180 days after the last dose of chemotherapy).
Exclusion criteria
Exclusion criteria: 1. Malignant diseases other than head and neck squamous cell carcinoma (excluding radical basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection carcinoma in situ) diagnosed within 5 years before the first dose; 2. Are currently participating in an interventional clinical study treatment, or have received another study drug or study device within 4 weeks before the first dose; 3. Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent targeting another T-cell receptor that stimulates or coinhibits it (e.g., CTLA-4, OX-40, CD137); 4. Received anti-tumor indications of Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin) systemic treatment within 2 weeks before the first dose; 5. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, glucocorticoids, or immunosuppressive agents) occurred within 2 years before the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) were not considered systemic therapy; 6. Receiving systemic glucocorticoids (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days before the first study dose; Note: Physiologic doses of glucocorticoids (= ? degree heart block, ventricular arrhythmia or atrial fibrillation; 2) unstable angina, congestive heart failure, New York Heart Association (NYHA) grade >= 2 chronic heart failure; 3) any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| main pathological remission, MPR;pathological complete response, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate, ORR;Disease Free Survival, DFS;Overall Survival, OS; | — |
Countries
China
Contacts
Public ContactSongnan Zhang
Affiliated Hospital of Yanbian University
Outcome results
None listed