Exploring the efficacy and safety of Tislelizumab combined with stereotactic body radiation therapy (SBRT) as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (HNSCC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
SBRT
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGNumber of Participants with MPR
MPR is defined as \< 10% of surviving tumor cells.
Time frame: From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months
Number of Participants with pCR
pCR is defined as the absence of viable tumor cells in the postoperative specimen.
Time frame: From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months
Number of Participants with downstaging in Clinical Pathological Staging as assessed by the AJCC 8th Edition Staging System
Utilization of the AJCC 8th Edition Staging System for Downstaging from Clinical to Pathological Staging
Time frame: From date of first day until the date of obtaining postoperative pathology, assessed up to 4 months
Median Progression-Free Survival
The time corresponding to a cumulative progression-free survival rate of 50%
Time frame: The time corresponding to a cumulative progression-free survival rate of 50%
Median Overall Survival
The time corresponding to a cumulative overall survival rate of 50%. Survival rate is defined as the time from the initiation of the first treatment to death from any cause.
Time frame: The time corresponding to a cumulative overall survival rate of 50%
Safety
Assessment of treatment-related adverse events using the Common Terminology Criteria for Adverse Events (CTCAE 5.0) is conducted from the initiation of neoadjuvant therapy through 30 days post-completion of all treatments. Adverse reactions are defined as adverse events related to the investigational drug with a relationship deemed "definitely related/possibly related/unable to determine.
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Time frame: From the commencement of neoadjuvant therapy until 30 days post-completion
Assessment of Quality of Life
The Quality of Life (QoL) was assessed at baseline and during follow-up using the European Organization for the Head and Neck Cancer Module (QLQ-H\&amp;N35) version 1.0, which represent functions, symptoms, or health conditions. The European Organization for Cancer Research and Treatment QLQ-C30 (EORTC QLQ-C30): a quality of life instrument for use in international clinical trials in oncology. The evaluation was performed before treatment, 15 minutes after each cycle of chemotherapy, and 3 and 6 months after the end of treatment. A total of 30 items are included. Each item is graded from 1 to 4, except for items 29 and 30, indicating not at all, a little, quite a bit, and very much, with higher scores indicating poorer quality of life.
Time frame: Before treatment, prior to surgery, and within one week after all treatments are completed.