This prospective, single-arm, Phase II study aims to evaluate the efficacy, safety, and surgical conversion rate of Cetuximab combined with Tislelizumab and chemotherapy for unresectable LA HNSCC.
The subject voluntarily participates, signs the Informed Consent Form (ICF), and is able to comply with the study procedures;
Patients with locally advanced head and neck squamous cell carcinoma confirmed by cytology or histology, for whom complete surgical resection is difficult;
No prior treatment for head and neck squamous cell carcinoma;
No prior treatment with cetuximab or PD-(L)1 inhibitors;
Previous anti-tumor treatments received (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
Known or suspected allergy to any component of cetuximab or PD-(L)1 monoclonal antibodies, as well as to the chemotherapeutic drugs paclitaxel and cisplatin;
Patients with hypertension that cannot be controlled to normal range with antihypertensive medications (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), patients with coronary heart disease of grade II or above, grade II arrhythmia (including QTc interval prolongation >470 ms), and grade I cardiac insufficiency;
History of autoimmune diseases or autoimmune disease history (such as colitis, hepatitis, hyperthyroidism, including but not limited to these diseases or syndromes), immunodeficiency history, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation;