Phase II Trial of Nimotuzumab with Immunotherapy and Chemotherapy Before Surgery for Locally Advanced Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining nimotuzumab with immunotherapy and chemotherapy as a pre-surgery neoadjuvant treatment for patients with locally advanced head and neck squamous cell carcinoma LA-HNSCC. This phase II randomized controlled trial aims to measure the two-year event-free survival rate among participants. The study expects to enroll patients over two years, with all participants followed for at least two years after enrollment ends. Participants in the experimental group receive nimotuzumab injections, albumin-bound paclitaxel or docetaxel, cisplatin or carboplatin chemotherapy, and either tislelizumab or pembrolizumab immunotherapy in two treatment cycles before surgery. The control group undergoes standard surgical treatment for the cancer. After surgery, additional treatments such as chemoradiotherapy may be given, including radiotherapy and weekly doses of cisplatin and nimotuzumab. Throughout the study, participants undergo various assessments including tumor tissue testing for PD-L1, monitoring for measurable lesions, and quality of life evaluations at multiple time points. Researchers track responses such as major pathological response, pathological complete response, objective response rate after treatment cycles, overall survival over two years, and event-free survival. Safety and adherence are monitored, and follow-up visits continue for at least two years after the last patient is enrolled.

Nimotuzumab Combined With Immunotherapy and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma