This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
148
SBRT for metastatic lesions
LDRT for metastatic lesions
6 cycles for combined therapy. Toripalimab maintenance for 1 year.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival
Defined as the time from randomization to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: up to 12 months
Overall Survival
Defined as the time from randomization to death from any cause.
Time frame: up to 12 months
Objective Response Rate
The percentage of patients with CR and PR assessed according to RECIST v1.1.
Time frame: up to 12 months
Disease Control Rate
The proportion of patients who have achieved complete response, partial response and stable disease according to RECIST v1.1.
Time frame: up to 12 months
Adverse Events
All adverse event or serious adverse event that occurred during the study period according to CTCAE v 4.03
Time frame: up to 12 months
QoL
Assessed by EQ-5D-5L questionnaire
Time frame: up to 12 months
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6 cycles for combined therapy.
6 cycles for combined therapy.
IMRT for primary lesion