Cetuximab Combined With Tislelizumab and Chemotherapy in the Treatment of Unresectable Locally Advanced Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm, Phase II Study
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;
• At least one measurable lesion according to RECIST v1.1;
• No gender restriction, age ≥18;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Expected survival period ≥ 3 months;
• Organ function levels meet the following criteria:
∙ Blood routine: Hemoglobin ≥90 g/L, absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥90×10\^9/L;
‣ Blood biochemistry: ALT, AST ≤2.5×ULN (≤5×ULN if liver metastasis is present), total serum bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN, serum albumin ≥30 g/L;
‣ Cardiac function: Left ventricular ejection fraction \>50% as shown by echocardiography.
⁃ Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the trial drug.