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.
Active autoimmune disease requiring systemic therapy (i.e., use of disease-modifying medications, corticosteroids, or immunosuppressants) within the previous 2 years. Replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic treatments.
Diagnosed with immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial therapy. After consultation with the sponsor, the use of physiologic doses of corticosteroids may be approved.
Other malignancies that are known to be progressing or requiring active treatment. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has received curative therapy are excluded.
Have an active infection requiring systemic therapy.
Parallel
Sintilimab
DrugSintilimab is administered intravenously on the first day of each cycle. 21 days per cycle.
Placebo
DrugPlacebo is administered intravenously on the first day of each cycle. 21 days per cycle.
PFS
progression-free survival
1-year PFS
1-year progression-free survival
OS
Overall Survival
Safety and tolerability
All adverse events will be assessed by the investigator in accordance with NCI Common Terminology for Adverse Events (CTCAE) version 5.0.
EORTC Quality of Life Questionnaire Head and Neck (H&N)-35 scores
Assessment of quality of life of HNSCC
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