Nimotuzumab Combined With Immunotherapy and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
A Prospective, Randomized, Phase II Study of Nimotuzumab Combined With Immunotherapy and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
182 participants
Apr 20, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
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Interventions
Nimotuzumab 400mg，d3，Q3W，for two cycles。
tislelizumab (or pembrolizumab) 200mg，d1，Q3W，for two cycles。
Albumin-bound paclitaxel 180 mg/m² (or docetaxel 75 mg/m²), administered on day 3, every 3 weeks (Q3W);for two cycles。
Cisplatin 75 mg/m² (carboplatin AUC=5 may be substituted if cisplatin is not tolerated), administered on day 3, every 3 weeks (Q3W).for two cycles。
Standard radical surgery of tumor
Concurrent chemoradiotherapy： Radiotherapy: intensity modulated conformal radiotherapy (IMRT) was used with a total dose of 60-66gy (2gy/f, 30-33f). Chemotherapy: Cisplatin 40 mg/m2, QW, 6-7 times in total; Targeting: nimotuzumab 200mg, QW, 6-7 times in total.
Locations(1)
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NCT07601737