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.
The experimental group and the control group start treatment within 1 month after the end of chemoradiotherapy, and Sintilimab was given intravenously on the first day of each cycle in the experimental group while placebo was given in the control group, and a cycle of 21 days, and a total of 18 cycles were expected to be administered, or until disease progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
Sintilimab is administered intravenously on the first day of each cycle. 21 days per cycle.
Placebo is administered intravenously on the first day of each cycle. 21 days per cycle.
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGPFS
progression-free survival
Time frame: 3 years
1-year PFS
1-year progression-free survival
Time frame: 1 year
OS
Overall Survival
Time frame: 3 years
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.
Time frame: 3 years
EORTC Quality of Life Questionnaire Head and Neck (H&N)-35 scores
Assessment of quality of life of HNSCC
Time frame: 3 years
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