The goal of this clinical trial is to learn about the efficacy and safety of pablizumab combined with neoadjuvant chemotherapy in patients with locally advanced head and neck squamous cell carcinoma. The main question it aims to answer is: Pathological complete remission (PCR) rate of tumor after neoadjuvant immunotherapy. Participants will be asked to perform CT and MRI of head and neck, ultrasonography of cervical lymph nodes and necessary laboratory examinations Before and after neoadjuvant therapy. And will be following-up for at least 1 year.
The secondary questions it aims to answer are: Objective response rate (ORR) after neoadjuvant therapy * R0 resection rate * major pathological remission (MPR) rate * organ preservation rate * event-free survival (EFS) * local recurrence-free survival (LRFS) * distant metastasis-free survival (DMFS) * quality of life score (QoL) * overall survival (OS) * incidence of adverse events (including neoadjuvant stage AEs and full course AEs) The exploratory question it aims to answer is: clearance of peripheral blood ctDNA.
Study Type
OBSERVATIONAL
Enrollment
45
Pathological complete remission (pCR) rate of tumor after neoadjuvant immunotherapy.
pCR means that there are no residual living tumor cells in the tumor bed and lymph nodes after neoadjuvant therapy.
Time frame: About 50 days after the start of neoadjuvant immunotherapy.
ORR(objective response rate)
Objective response rates after neoadjuvant immunotherapy were measured, usually as the proportion of patients whose tumor volume decreased by 30% and maintained over 4 weeks, that is, the sum of the rates of complete response (CR) and partial response (PR) , the higher the ORR, the more patients achieved tumor shrinkage with the treatment.
Time frame: At least 1 year.
R0 resection rate
R0 resection is the highest standard of tumor resection, which means complete tumor resection with negative margin. The tumor R0 resection rate was calculated for the patients who underwent surgery after the completion of neoadjuvant immunotherapy.
Time frame: At least 1 year.
MPR(major pathological response)
MPR is defined as the percentage of residual tumor cells in the tumor bed being less than or equal to 10% .
Time frame: At least 1 year.
Overall survival rate
Overall survival is the proportion of all participants who survived the study period. Overall survival was calculated by dividing the number of people alive by the total number at the start of the study.
Time frame: At least 1 year.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Researchers should grade the severity of each adverse event. If the severity/intensity of an adverse event is not specified in the guidelines, the investigator can assess it based on the general definition of grade 1-5 and in conjunction with his or her medical judgment.
Time frame: At least 1 year.
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