OncoMatch/Clinical Trials/NCT07277764
Induction High-Low Dose Radiotherapy Plus Anti-PD-1 Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma (Single-Arm Phase II)
Is NCT07277764 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies non-drug interventions for nasopharyngeal carcinoma (npc).
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 weeks after radiotherapy for up to 12 months or until progression/toxicity. The primary endpoint is ORR at 3 months post-radiotherapy; secondary endpoints include 3-year OS, 3-year PFS, safety (NCI-CTCAE v5.0), and quality of life (EORTC QLQ-C30). Key eligibility: histologically confirmed non-keratinizing NPC (WHO II/III), rT2-rT4, ECOG 0-1, adequate organ function.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage RT2, RT3, RT4
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: radical therapy — prior
local (± regional) recurrence ≥1 year after prior radical therapy
Cannot have received: anti-PD-1 therapy
prior PD-1/PD-L1 therapy
Cannot have received: anti-PD-L1 therapy
prior PD-1/PD-L1 therapy
Lab requirements
Blood counts
per protocol thresholds
Kidney function
per protocol thresholds
Liver function
per protocol thresholds
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07277764 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1 therapy, anti-PD-L1 therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage RT2 or RT3 or RT4 is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages