This is a randomized controlled, phase II clinical study designed to explore the efficacy and safety of nimotuzumab combined with immunotherapy and chemotherapy as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The primary endpoint of the study is the 2-year event-free survival (EFS) rate. Enrollment is expected to be completed within 2 years; all patients will be followed up for at least 2 years after the last patient is enrolled.
Age 18 to 75 years inclusive.
Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (HNSCC) (oral cavity, oropharynx, larynx, hypopharynx), stage III-IVB per AJCC 8th edition.
Resectable disease assessed by a multidisciplinary team (MDT) including surgical, radiological, and pathological specialists.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Received PD-1 inhibitors, EGFR monoclonal antibodies, EGFR-TKIs, or anti-angiogenic agents within 4 weeks prior to enrollment.
Participation in another interventional clinical trial within 30 days prior to screening.
In the investigator's judgment, the patient cannot tolerate or has contraindications to platinum-based chemotherapy (cisplatin or carboplatin) as specified in the protocol.
Unresectable disease, poor medical condition for surgery, refusal of surgery for any reason, or excessive tumor burden precluding resection.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead sponsor