High-low dose radiation plus anti-PD-1 followed by full-course radiation for recurrent nasopharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm, single-center Phase II protocol delivers three fractions of low-dose radiotherapy plus three high-dose boosts to the tumor core together with anti-PD-1 (240 mg IV on Day 1 and Day 22) as induction. After a 21–28 day interval participants receive definitive IMRT (2 Gy ×28 fractions) without concurrent immunotherapy, then begin anti-PD-1 maintenance (240 mg IV every 3 weeks) for up to 12 months or until progression or unacceptable toxicity. The primary endpoint is objective response rate at 3 months after radiotherapy; secondary endpoints include 3-year overall survival, 3-year progression-free survival, safety per CTCAE v5.0, and quality of life by EORTC QLQ-C30. Key inclusion criteria are histologically confirmed non-keratinizing NPC (WHO II/III), local recurrence ≥1 year after prior therapy, rT2–rT4 disease, ECOG 0–1, adequate organ function, and no distant metastases or prior PD-1/PD-L1 therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria：

Histologically confirmed non-keratinizing NPC (WHO II/III); local (± regional) recurrence ≥1 year after prior radical therapy; surgery-ineligible;

rT2-rT4 (AJCC 8th); ECOG 0-1;

Adequate organ function (hematologic, hepatic, renal, coagulation per protocol thresholds);

Contraception requirements per protocol; signed informed consent.

Exclusion Criteria：

Distant metastasis at recurrence; active necrosis at recurrence; active/previous autoimmune disease; prior PD-1/PD-L1 therapy; uncontrolled comorbidities; active infections (HBV/HCV/HIV criteria per protocol); interstitial lung disease/pneumonitis; pregnancy/lactation; other protocol-specified exclusions.

Where it's running

• Jiangxi Cancer Hospital
  Nanchang, Jiangxi, China Recruiting

Study contacts

• Study coordinator: Jingao Li Prof. Jingao Li, MD
• Email: ndzhlyy0005@ncu.edu
• Phone: 8613970866296

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.