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 (May 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)
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.
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