This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with recurrent/metastatic nasopharyngeal carcinoma who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of camrelizumab in combination with gemcitabine and cisplatin with placebo in combination with gemcitabine and cisplatin in study population in China. camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.
In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Treatment cycles of chemotherapy will be at most 6 weeks which will be decided by investigators. Progression-free survival (PFS) determined by the Independent Review Committee (IRC) will be the primary outcome measures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
263
Maximum 6 cycles for combined therapy. Camrelizumab maintenance.
Maximum 6 cycles for combined therapy.
Maximum 6 cycles for combined therapy.
Cancer Center of Sun-Yat Sen University (CCSYSU)
Guangzhou, Guangdong, China
Progression-free survival (PFS)
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee according to RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: up to 24 month
Progression-free survival
Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1
Time frame: up to 24 month
Objective Response Rate (ORR)
The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1
Time frame: up to 24 month
Disease Control Rate (DCR) Disease Control Rate (DCR)
The proportion of patients who have achieved complete response, partial response and Stable disease assessed by investigators according to Recist v 1.1
Time frame: up to 24 month
Duration of Response (DoR)
According to Recist v 1.1 accessed by investigators
Time frame: up to 24 month
2 years Overall Survival (OS) rate
The percentage of patients overall survival in 2 years
Time frame: up to 24 month
Adverse Events (AEs)
All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03
Time frame: up to 24 month
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Maximum 6 cycles for combined therapy.