Induction Therapy With High-Low Dose Radiotherapy Combined With Anti-PD-1 Monoclonal Antibody Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma: A Single-Arm, Single-Center Phase II Trial

What this Trial Is About

Researchers are evaluating a new radio-immunotherapy approach for patients with recurrent nasopharyngeal carcinoma (NPC) who cannot undergo surgery. This phase II, single-center trial aims to assess the safety and effectiveness of combining low-dose and high-dose radiotherapy with an anti-PD-1 antibody. The study focuses on patients with confirmed non-keratinizing NPC who have experienced local or regional recurrence at least one year after previous radical treatment and have good general health status. The treatment starts with an induction phase consisting of three low-dose radiotherapy sessions plus three high-dose boosts targeting the tumor core, combined with two doses of anti-PD-1 antibody given intravenously on Day 1 and Day 22. After a 21 to 28-day break, patients receive definitive intensity-modulated radiotherapy (IMRT) five days a week without concurrent immunotherapy to reduce immune damage. Following radiotherapy, anti-PD-1 maintenance therapy is administered intravenously every three weeks for up to 12 months or until disease progression or unacceptable side effects occur. Participants will be monitored for tumor response three months after completing radiotherapy, which is the primary outcome measure. Secondary outcomes include overall survival and progression-free survival over three years, safety assessments throughout treatment and follow-up, and quality of life evaluations. Researchers will perform regular clinical assessments, laboratory tests, and imaging studies to track treatment effects and side effects. The total study duration may extend up to several years for long-term follow-up.

Induction High-Low Dose Radiotherapy Plus Anti-PD-1 Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma (Single-Arm Phase II)