We intend to compare the efficacy and safety of immunotherapy plus stereotactic body radiotherapy at oligometastatic lesions and immunotherapy alone among patients with oligometastatic nasopharyngeal carcinoma whose primary lesion has been well controlled after radical local-regional treatment through this multicenter randomized phase 3 trial.
Male or female; 18-70 years of age.
Primary lesion and regional lymph nodes completed radical radiotherapy 3 months before stereotactic body radiotherapy and diseases well controlled.
Underwent at least first-line systemic chemotherapy, regardless of regimen and curative effect.
Imageological evidence for oligometastatic lesions (metastatic tissue biopsy preferred but not necessary). The number of total metastatic lesions no more than 5 and the number of metastatic lesions within a single organ no more than 3.
Immunotherapy (PD-1/PD-L1 or CTLA-4 monoclonal antibody) failure.
CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency.
History of severe hypersensitivity to any ingredient of PD-1/PD-L1 or other monoclonal antibody.
chemotherapy (cytotoxic or molecular targeted) within 4 weeks before stereotactic body radiotherapy.
Sun Yat-sen University
Lead sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborator
Zhongshan People's Hospital, Guangdong, China
Collaborator
Guangdong Provincial People's Hospital
Collaborator