A Randomized, Double-Blind, Multi-Center Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) + Serplulimab (HLX10, Recombinant Anti-PD-1 Humanized Monoclonal Antibody) +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
1500 mg, D1,Q3W
300 mg, D1, up to 2 years,Q3W
1500 mg, D1,Q3W
gemcitabine 1000 mg/m2, D1,D8; cisplatin 80 mg/m2,D1;Q3W, up to 6 cycles
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China
ORR
Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria)
Time frame: up to 24 weeks
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by the IRRC and INV according to the RECIST v1.1 criteria.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 months
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