Actively Recruiting
Induction High-Low Dose Radiotherapy Plus Anti-PD-1 Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma (Single-Arm Phase II)
Led by Jiangxi Provincial Cancer Hospital · Updated on 2025-12-11
23
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Induction High-Low Dose Radiotherapy Plus Anti-PD-1 Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma (Single-Arm Phase II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO II/III)
- Local or regional recurrence at least 1 year after prior radical therapy
- Not eligible for surgery
- Tumor stage rT2 to rT4 (AJCC 8th edition)
- ECOG performance status 0 or 1
- Adequate organ function including hematologic, liver, kidney, and coagulation per protocol
- Use of contraception as required by the protocol
- Signed informed consent
You will not qualify if you...
- Presence of distant metastasis at recurrence
- Active necrosis at recurrence site
- Active or previous autoimmune disease
- Prior treatment with PD-1 or PD-L1 therapy
- Uncontrolled serious medical conditions
- Active infections including hepatitis B, hepatitis C, or HIV as defined by protocol
- Interstitial lung disease or pneumonitis
- Pregnancy or breastfeeding
- Other protocol-specified exclusion criteria
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Actively Recruiting
Research Team
J
Jingao Li Prof. Jingao Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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