PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Salvage Locoregional Radiotherapy i… (NCT07235319) | Clinical Trial Compass
RecruitingPhase 3
PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Salvage Locoregional Radiotherapy in De Novo Metastatic NPC
China260 participantsStarted 2025-11-20
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age 18-70 years, any gender.
✓. Histologically confirmed differentiated non-keratinizing carcinoma or undifferentiated non-keratinizing carcinoma by tissue biopsy, with radiologically detectable metastatic lesions. Pathological confirmation of metastatic lesions is recommended but not mandatory.
✓. ECOG performance status 0-1.
✓. Stage IV NPC according to the 9th edition of the UICC/AJCC staging system.
✓. No prior anti-tumor treatment for NPC (radiotherapy, chemotherapy, surgery, etc.).
✓. Expected survival ≥ 3 months.
✓. At least one measurable lesion per RECIST v1.1.
✓. Achieved complete response (CR) or partial response (PR) after 4-6 cycles of chemotherapy plus PD-1 inhibitor therapy.
Exclusion criteria
✕. Prior anti-tumor therapy for nasopharyngeal carcinoma, including radiotherapy, chemotherapy, surgery, or immunotherapy.
✕. Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors.
✕. Presence of uncontrolled or symptomatic central nervous system (CNS) metastases.
✕. History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell skin cancer, or in-situ cervical cancer.
✕. Active autoimmune disease or history of autoimmune disease requiring systemic treatment (e.g., corticosteroids, immunosuppressants) within the past 2 years, except for stable hypothyroidism, type 1 diabetes mellitus, or resolved childhood asthma/atopy.
✕. Known history of active pulmonary tuberculosis (TB). Suspected active TB must be excluded by chest X-ray, sputum examination, and assessment of clinical signs and symptoms.
✕. Hepatitis B: HBsAg positive with peripheral blood HBV DNA ≥ 1000 copies/mL
✕. Hepatitis C: HCV antibody positive, eligible only if HCV RNA is negative