Induction High-Low Dose Radiotherapy Plus Anti-PD-1 Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma (Single-Arm Phase II)
Recruiting
Phase 2
Interventional Study
Nasopharyngeal Carcinoma (NPC)
Recurrent Nasopharyngeal Neoplasms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 23 (estimated)
- Sponsor
- Jiangxi Provincial Cancer Hospital · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
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);
Contrac…
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