Study of EGFR Antibody with PD-1 Inhibitor and Chemotherapy for Adults with Recurrent or Metastatic Nasopharyngeal Carcinoma

What this Trial Is About

Researchers are evaluating the effectiveness and side effects of combining an EGFR antibody with a PD-1 antibody and chemotherapy for patients with recurrent or metastatic nasopharyngeal carcinoma. This study is a prospective, single-arm, phase II clinical trial focused on this specific patient group to better understand treatment outcomes. The study is sponsored by Sun Yat-sen University. Participants will receive a combination of EGFR antibody, PD-1 antibody, and chemotherapy drugs Gemcitabine and Cisplatin for six cycles. The EGFR and PD-1 antibodies will continue as maintenance therapy for one year. Additionally, intensity-modulated radiation therapy IMRT may be applied to the primary tumor site. These treatments are delivered as part of a multi-center clinical trial. During the trial, participants will be closely monitored through various assessments including progression-free survival over one year, adverse events up to 16 months, overall survival, objective response rate, disease control rate, and quality of life measures. Laboratory tests, imaging, and clinical evaluations will be performed to track safety and treatment effects. The total duration of participation varies depending on the treatment and follow-up periods.

EGFR Antibody Combined With PD-1 Inhibitor and Chemotherapy in R/M Nasopharyngeal Carcinoma