This trial is aimed to investigate whether adjuvant PD-1 antibody treatment could improve survival in locoregionally advanced nasopharyngeal carcinoma compared to best supportive care.
In this multicenter, randomised controlled, phase 3 trial, patients with stage III-IVA (AJCC/UICC 8th system, except T3-4N0 and T3N1) non-metastatic nasopharyngeal carcinoma will be randomized in a 1:1 ratio to recieve PD-1 antibody for 12 doses every 3 weeks or best supportive care after curative chemoradiation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
450
Camrelizumab is an antibody targeting PD-1 developed by Jiangsu Hengrui Medicine, China.
First People's Hospital of Foshan
Foshan, Guangdong, China
Guangzhou Medical University Cancer Hospital
Guangzhou, Guangdong, China
Panyu central hospital
Guangzhou, Guangdong, China
failure-free survival
calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.
Time frame: 3 years
overall survival
calculated from date of randomisation to death
Time frame: 5 years
distant metastasis-free survival
calculated from date of randomisation to the first distant failure
Time frame: 3 years
locoregional recurrence-free survival
calculated from date of randomisation to the first locoregional failure
Time frame: 3 years
adverse events (AEs) and severe adverse events (SAE)
graded according to NCI CTCAE v5.0
Time frame: 3 years
quality of life (QoL)
the change of QoL from randomization to 36 months after chemoradiation, graded according to EORTC QLQ-C30 V3.0
Time frame: 3 years
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Xijing Hospital, Fourth Military Medical University
Xi’an, Shanxi, China
...and 1 more locations