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Nimotuzumab Combined With Immunotherapy and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
182
Start Date
2026-04-20
Completion Date
2030-04-30
Last Updated
2026-07-09
Healthy Volunteers
No
Conditions
Interventions
Nimotuzumab Injection
Nimotuzumab 400mg,d3,Q3W,for two cycles。
Tislelizumab
tislelizumab (or pembrolizumab) 200mg,d1,Q3W,for two cycles。
Albumin-Bound Paclitaxel /nab-Paclitaxel
Albumin-bound paclitaxel 180 mg/m² (or docetaxel 75 mg/m²), administered on day 3, every 3 weeks (Q3W);for two cycles。
Cisplatin (Or Carboplatin)
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。
Radical surgery of tumor
Standard radical surgery of tumor
Concurrent chemoradiotherapy
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)
Shanghai First People's Hospital
Shanghai, China