Phase II Study of Envafolimab Combined with Chemoradiotherapy for Treating Locally Advanced Nasopharyngeal Carcinoma

What this Trial Is About

Researchers are evaluating the combination of Envafolimab with chemoradiotherapy for patients diagnosed with locally advanced nasopharyngeal carcinoma. This prospective, single-arm phase II trial aims to assess the three-year progression-free survival of these patients. Envafolimab is a PD-L1 antibody administered by hypodermic injection, studied here alongside curative chemoradiotherapy to better understand its potential impact on this condition. Participants will first receive three cycles of induction chemotherapy combining GP gemcitabine plus cisplatin with Envafolimab. Following this, they will undergo concurrent chemoradiotherapy using intensity-modulated radiotherapy IMRT delivering a dose of 68-70 Gy over 30-33 fractions, five days a week for six to seven weeks. During radiotherapy, patients receive two cycles of cisplatin and Envafolimab concurrently. Afterwards, they continue receiving Envafolimab every three weeks for maintenance treatment for up to one year or until disease progression or intolerance. During the study, participants will be closely monitored with regular assessments to track disease progression and treatment tolerance. The main outcome measured is the three-year progression-free survival, reflecting the length of time patients remain free from disease progression. The entire course of treatment and follow-up will span up to one year of maintenance therapy, with ongoing safety and response evaluations throughout the trial period.

Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.