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.
We intend to apply camrelizumab plus stereotactic body radiotherapy at oligometastatic lesions to patients with oligometastatic nasopharyngeal carcinoma whose primary lesion has been well controlled after radical treatment through this multicenter randomized phase 3 trial to investigate whether stereotactic body radiotherapy at oligometastatic lesions on the basis of immunotherapy can achieve clinical cure among a part of patients with distant metastasis and improve their overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy
Patients 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.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGMedian 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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
Adverse events
NCI-CTC5.0 and RTOG standards are adopted, and acute subjective toxicity, acute objective toxicity and late subjective toxicity are included.
Time frame: 2 year
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
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Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Time frame: 2 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment.
Time frame: 2 years.