Actively Recruiting
PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Selective Re-irradiation for Locally Advanced Recurrent NPC
Led by Sun Yat-sen University · Updated on 2026-02-04
94
Participants Needed
1
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II randomized trial evaluates PD-1 inhibitor plus chemotherapy followed by immediate versus selective re-irradiation in locally advanced recurrent nasopharyngeal carcinoma. The study aims to determine whether sequential radiotherapy provides additional survival benefit beyond systemic immunochemotherapy.
CONDITIONS
Official Title
PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Selective Re-irradiation for Locally Advanced Recurrent NPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years, any gender
- Local recurrence (with or without regional recurrence) more than one year after radical treatment and not suitable for surgery
- Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III)
- Achieved complete or partial response after 4 to 6 cycles of chemotherapy plus PD-1 inhibitor therapy
- ECOG performance status 0 or 1
- Expected survival of 3 months or longer
- No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent nasopharyngeal carcinoma
- No contraindications to immunotherapy, chemotherapy, or re-irradiation
- Adequate organ function within 14 days before starting treatment, including hemoglobin ≥ 90 g/L, ANC ≥ 1.5 x 10⁹/L, platelet count ≥ 100 x 10⁹/L, creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min, total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases present
- INR or PT ≤ 1.5 x ULN unless on therapeutic anticoagulation within range, APTT ≤ 1.5 x ULN unless on therapeutic anticoagulation within range
You will not qualify if you...
- Presence of grade 3 or higher late radiation toxicity (excluding skin, subcutaneous tissue, and mucosa) at the time of recurrence
- Prior anti-tumor therapy for recurrent nasopharyngeal carcinoma, including radiotherapy, chemotherapy, surgery, or immunotherapy
- Previous treatment with PD-1/PD-L1 or CTLA-4 inhibitors
- History of other cancers within the past 5 years except treated basal cell carcinoma, squamous cell skin cancer, or in-situ cervical cancer
- Active or recent autoimmune disease requiring systemic treatment within the past 2 years except stable hypothyroidism, type 1 diabetes, or resolved childhood asthma/atopy
- Known active pulmonary tuberculosis or suspected active TB not ruled out
- Hepatitis B with positive HBsAg and HBV DNA ≥ 1000 copies/mL
- Hepatitis C antibody positive unless HCV RNA negative
- HIV infection
- Significant cardiovascular disease such as uncontrolled hypertension, recent heart attack, congestive heart failure class II or higher, or serious arrhythmia
- Interstitial lung disease, non-infectious pneumonitis, or history of grade 2 or higher pneumonitis
- Major surgery within 4 weeks before enrollment or unhealed surgical wound
- Pregnant or breastfeeding, or planning pregnancy during the study
- Known allergy or hypersensitivity to study drugs or their ingredients
- Any condition judged by the investigator to interfere with study participation or result interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
H
Haiqiang Mai, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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