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.
Parallel
camrelizumab
DrugPatients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy
stereotactic body radiotherapy
RadiationPatients receive stereotactic body radiotherapy for all oligometastatic lesions as radical therapy to control the disease and reduce any potential adverse impact to living quality. The dosage is based on published clinical studies.
Median progression-free survival (PFS)
Progression-free survival is calculated from the date of randomization to the date of death of any cause or the first progress at any site, censored on the last date of tumor evaluation if no progress has happened.
Objective response rate (ORR)
Objective response rate is the rate of patients achieving complete response or partial response for a certain period of time after intervention.
Disease control rate (DCR)
Disease control rate is the rate of patients achieving complete response, partial response or stable disease for at least 4 weeks after intervention.
Clinical benefit rate (CBR)
Clinical benefit rate is the rate of patients achieving complete response, partial response or stable disease for at least 6 months after intervention.
Median overall survival (OS)
Overall survival is calculated from the date of randomization to the date of death of any cause, censored on the last date of known survival if no death has happened.
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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
