Nimotuzumab with Induction Chemotherapy, Chemoradiation, and Adjuvant Therapy for Advanced Nasopharyngeal Carcinoma

What this Trial Is About

Researchers are evaluating the combination of nimotuzumab, a humanized monoclonal antibody targeting the epidermal growth factor receptor EGFR, with induction chemotherapy, chemoradiation, and adjuvant therapy in patients with locoregionally advanced nasopharyngeal carcinoma. This multi-center, randomized controlled trial aims to assess the therapeutic effectiveness and safety of this combined treatment approach in this cancer type. Participants are assigned to one of two groups the experimental group receives induction chemotherapy with nimotuzumab, gemcitabine, and cisplatin followed by intensity-modulated radiotherapy IMRT combined with weekly nimotuzumab and cisplatin, then adjuvant nimotuzumab every three weeks for eight cycles after IMRT. The control group receives induction chemotherapy with gemcitabine and cisplatin, IMRT combined with weekly nimotuzumab and cisplatin, but no adjuvant nimotuzumab. During the study, participants will undergo regular treatment cycles, radiotherapy sessions, and follow-up assessments over five years. Researchers will monitor overall survival, tumor control, disease-free survival, locoregional failure-free survival, distant metastasis-free survival, adverse events, and quality of life using questionnaires. Safety and treatment effects will be closely observed throughout the trial period, which lasts until November 2027.

Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma