A Prospective Randomized Controlled Study of Immune Checkpoint Maintenance Therapy After Radiotherapy and Chemotherapy for Locally Advanced Head And Neck Tumors Based on Peripheral Blood CD8Tex Detection in Peripheral Blood
The goal of this prospective, randomized, single-blind controlled clinical study is to explore the efficacy of maintenance therapy with Sintilimab after chemoradiotherapy in locally advanced head and neck squamous cell carcinoma. The main questions it aims to answer are: How works well the Sintilimab was in the treatment group？ How safe the Sintilimab is？ Participants will intravenous Sintilimab or placebo (a look-alike substance that contains no active drug) within 1 month after the end of chemoradiotherapy, and 21 days is a cycle. Blood tests, electrocardiogram are rechecked every 2 cycles, and CT was rechecked every 4 cycles to evaluate toxicity and side effects and recurrence. Researchers will compare invention group to control group to see if the Sintilimab works well.
• Male or female, age ≥ 18 years old, ≤ 75 years old.
• Histologically confirmed inoperable locally advanced head and neck tumor T3 or N+ or above.
• Patients undergoing concurrent chemoradiotherapy
• ECOG performance status of 0 to 1.
• Life expectancy of at least 12 weeks.
• At least one measurable lesion
• Blood test: absolute neutrophil count (ANC) \> 1.5×109/L, hemoglobin \> 8g/dL and platelet \> 100 ×109/L (subject to the normal value of the clinical trial center).
• Prothrombin time (PT) \<1.5 times the upper limit of normal and normal thromboplastin time (APTT) \<1.5 times the upper limit of normal.
• Laboratory examination, serum creatinine less than or equal to 1.5 times the upper limit of the reference range of normal values (If serum creatinine is elevated, 24-hour urine must be collected. Except for the 24-hour creatinine clearance rate is \> 50ml/min).
⁃ In the absence of liver metastases, ALT or AST is less than or equal to 2.5 times the upper limit of the reference range of normal values, and total serum bilirubin is less than or equal to 1.5 times the upper limit of the reference range of normal values; for patients with liver metastases, ALT or AST is less than or equal to 5 times the upper limit of the reference range of normal values, and total serum bilirubin is less than or equal to 3 times of the upper limit of the reference range of normal values.
⁃ Females of childbearing potential must be willing to use adequate contraception for the duration of study drug treatment.
⁃ Signed informed consent.
⁃ At the end of radiotherapy, the proportion of PD1+CD8T cells in peripheral blood is greater than 10%, or more than 2 times higher than baseline