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

This single-arm, single-center phase II trial evaluates the safety and efficacy of a non-continuous radio-immunotherapy strategy for recurrent nasopharyngeal carcinoma (NPC) unsuitable for surgery. Induction consists of three fractions of low-dose radiotherapy (1.5 Gy ×3) plus high-dose boosts (5 Gy ×3 to tumor core with carotid/mucosal sparing) combined with anti-PD-1 (240 mg IV on Day 1 and Day 22). After a 21-28-day interval, definitive IMRT (2 Gy ×28, 5 days/week) is delivered without concurrent immunotherapy to minimize immune damage. Anti-PD-1 maintenance (240 mg IV Q3W) starts within 2

Trial Details

NCT ID
NCT07277764
Phase
PHASE2
Sponsor
Jiangxi Provincial Cancer Hospital
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • High-Low Dose Radiotherapy
Locations (sample)
  • Nanchang, Jiangxi, China|28.68396,115.85306

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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