This study aims to explore the optimal course of neoadjuvant immunotherapy for HNSCC by comparing the efficacy and safety of 4 cycles and 2 cycles of neoadjuvant tislelizumab combined with chemotherapy.
Histological or pathological diagnosis of head and neck squamous cell carcinoma;
Initially resectable stage III-IVB oral cancer/laryngeal cancer/hypopharyngeal cancer/P16-oropharyngeal cancer, or stage III p16+ oropharyngeal cancer (AJCC 8th), and evaluated by the researcher to achieve R0 resection;
Plan to perform neoadjuvant therapy;
No previous anti-tumor treatment for HNSCC;
Previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T-cell co-stimulation or checkpoint pathways);
There is a clear history of allergies, and there may be potential allergies or intolerances to the research drug and its similar biological agents;
Participated in clinical trials of other anti-tumor drugs within 4 weeks before the first administration; Or within 4 weeks before the first administration or planning to receive a live attenuated vaccine during the study period;
Other malignant tumors have occurred within the past five years (except for well-treated squamous cell carcinoma of the skin or controlled basal cell carcinoma of the skin);
Parallel
Tislelizumab Combined With Chemotherapy for 4 cycles
DrugTislelizumab: 200mg, day 1, every 3 weeks for 4 cycles Cisplatin: 75mg/m\^2, day 1, every 3 weeks for 4 cycles Nab-paclitaxel: 260mg/m\^2, day 1, every 3 weeks for 4 cycles
Tislelizumab Combined With Chemotherapy for 2 cycles
DrugTislelizumab: 200mg, day 1, every 3 weeks for 2 cycles Cisplatin: 75mg/m\^2, day 1, every 3 weeks for 2 cycles Nab-paclitaxel: 260mg/m\^2, day 1, every 3 weeks for 2 cycles
Pathological Complete Response (pCR)
Pathological complete response (pCR) is defined as having no residual invasive squamous cell carcinoma within the resected primary tumor specimen.
Major Pathological Response (mPR)
The percentage of participants with a major pathological response (mPR) is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen.
Organ perservation rate
Organ perservation rate defined as the proportion of patients who successfully preserved their organs and functions through neoadjuvant treatment.
Operation delay rate
Operation delay rate defined as any change to scheduled surgery date considered to be at least possibly related to neoadjuvant treatment.
Objective resopnse rate (ORR)
ORR defined as the proportion of all subjects who achieved complete response (CR) or partial response (PR) as assessed by RECIST V1.1 after the end of neoadjuvant therapy
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