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;
Single group
TP + Cetuximab + Tislelizumab
DrugConversion therapy stage: TP regimen: Albumin-bound paclitaxel+Platinum (Cisplatin or Carboplatin) Albumin-bound paclitaxel: 100 mg/m² by IV infusion, D1/D8, every 3 weeks (Q3W) Platinum: Cisplatin 75 mg/m² by IV infusion or Carboplatin AUC=5 mg/mL/min Q3W Cetuximab: The initial dose is 400 mg/m² by IV infusion for 1 week. Subsequently followed by 250 mg/m² IV infusion, D1/D8, Q3W. Tislelizumab: 200 mg by IV infusion, Q3W. 3 weeks/cycle, 3 cycles in total. Patients who have completed conversion therapy undergo efficacy evaluation. Radical therapy stage: Evaluated as operable: Undergo surgery, followed by one cycle of adjuvant chemotherapy according to the preoperative regimen. Evaluated as inoperable: Receive radical radiotherapy. Maintenance therapy stage: Tislelizumab for 1 year or until disease progression, intolerable toxicity, or patient refusal to continue treatment.
Objective Response Rate (ORR)
Defined as the proportion of participants acquired Complete response (CR) or Partial response (PR) after conversion treatment. Based on RECIST 1.1.
R0 resection rate
Defined as the proportion of patients in whom no cancer cells are detected at the resection margin microscopically, with no residual cancer cells visible either macroscopically or microscopically, and the lesion is completely excised.
Major Pathological Response Rate (MPR)
Defined as the presence of 10% or less viable tumor cells in the resected specimen following preoperative therapy, as assessed by pathological examination.
Progression free survival (PFS)
Defined as the period from enrollment to disease progress or death.
Overall Survival (OS)
Defined as the period from enrollment to death from any cause
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