To explore the efficiency and safety of TP chemotherapy, tislelizumab, combined with afatinib as a new neoadjuvant treatment regimen for patients with resectable HNSCC.
More than 60% of patients with Head and neck squamous cell carcinoma (HNSCC) have locally advanced or metastatic disease at the time of diagnosis, with a 5-year overall survival rate of less than 60%. The clinical outcomes of those patients still need to be improved. Neoadjuvant therapy theoretically could reduce tumor volume, increase organ retention rate, and improve clinical prognosis. However, results from several phase III clinical trials have not proved a significant survival benefit of neoadjuvant chemotherapy for patients with resectable HNSCC except for nasopharyngeal carcinoma. There is an urgent need to explore new neoadjuvant treatment options for those patients. Immunotherapy such as PD-1/PD-L1 inhibitors have shown excellent efficiency in the treatment of malignancies. Anti-PD-1 therapy is approved as the first-line treatment of recurrent/metastatic HNSCC. Neoadjuvant immunotherapy for the treatment of locally advanced and resectable HNSCC has been demonstrated to be feasible in some trials. Afatinib, as an irreversible ErbB tyrosine kinase inhibitor (TKI), has been used as the second-line treatment for recurrent and/or metastatic HNSCC. A previous study published in 2018 confirmed that afatinib can be administered safely before surgery. In summary, we designed this study to explore the efficiency and safety of chemotherapy (TP regimen), anti-PD1 immunotherapy (tislelizumab), combined with EGFR-TKI (afatinib) as a new neoadjuvant treatment regimen for patients with resectable HNSCC, aiming to provide a new treatment option for those patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Pathologic Complete Response
Pathologic complete response was defined as the absence of viable tumor cells.
Time frame: Time of surgery
Major Pathologic Response
Major pathologic response was defined as fewer than 10% viable tumor cells.
Time frame: Time of surgery
Objective Response Rate
Objective response rate was defined as the percentage of participants with a best overall response of CR or PR using RECIST Criteria
Time frame: Up to 8 weeks
Adverse Events
Adverse events included adverse events using CTCAE Criteria and unplanned surgery delays.
Time frame: Up to 12 weeks
Disease-free Survival
Disease-free survival was defined as the time from the administration of the first dose to first disease progression or death.
Time frame: 1 year
Overall Survival
Overall survival was defined as the time from the administration of the first dose to death.
Time frame: 1 year
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