Actively Recruiting
PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Salvage Locoregional Radiotherapy in De Novo Metastatic NPC
Led by Sun Yat-sen University · Updated on 2025-11-19
260
Participants Needed
5
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase III randomized trial evaluates PD-1 inhibitor plus chemotherapy followed by immediate versus salvage locoregional radiotherapy in de novo metastatic nasopharyngeal carcinoma. The study aims to evaluate whether salvage locoregional radiotherapy is non-inferior to immediate radiotherapy following PD-1 inhibitor plus GP in de novo metastatic NPC, with potential for reduced toxicity.
CONDITIONS
Official Title
PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Salvage Locoregional Radiotherapy in De Novo Metastatic NPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years, any gender
- Histologically confirmed differentiated or undifferentiated non-keratinizing nasopharyngeal carcinoma with radiologically detectable metastatic lesions
- ECOG performance status of 0 or 1
- Stage IV nasopharyngeal carcinoma according to the UICC/AJCC 9th edition
- No prior anti-tumor treatment for nasopharyngeal carcinoma
- Expected survival of at least 3 months
- At least one measurable lesion according to RECIST v1.1
- Achieved complete or partial response after 4 to 6 cycles of chemotherapy plus PD-1 inhibitor therapy
- Adequate organ function within 14 days before first dose, including specific blood counts, kidney and liver function
- INR or PT and aPTT within acceptable limits unless on therapeutic anticoagulation
You will not qualify if you...
- Prior anti-tumor therapy for nasopharyngeal carcinoma, including radiotherapy, chemotherapy, surgery, or immunotherapy
- Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors
- Uncontrolled or symptomatic central nervous system metastases
- Other malignancies within past 5 years except treated basal cell carcinoma, squamous cell skin cancer, or in-situ cervical cancer
- Active autoimmune disease or history requiring systemic treatment within past 2 years except stable hypothyroidism, type 1 diabetes, or resolved childhood asthma/atopy
- Known active pulmonary tuberculosis or suspected active TB not excluded
- Hepatitis B with high viral load
- Hepatitis C antibody positive unless RNA negative
- HIV infection
- Significant cardiovascular disease 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
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Known allergy or hypersensitivity to study drugs or excipients
- Any condition interfering with study participation or results interpretation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Hunan Cancer Hospital
Changsha, China
Not Yet Recruiting
3
Fujian Cancer Hospital
Fuzhou, China
Not Yet Recruiting
4
Zhejiang Cancer Hospital
Hangzhou, China
Not Yet Recruiting
5
Guangxi Medical University Cancer Hospital
Nanning, China
Not Yet 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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