This is a randomized, double-blind, multicenter, Phase 3 study to compare the efficacy and safety of LY01015 and Opdivo®(Nivolumab Injection)combined respectively with fluorouracil plus cisplatin in participants with unresectable advanced, recurrent or metastatic previously untreated esophageal squamous cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
510
Intravenouslly (IV) 240mg every 2 weeks (Q2W) during the combined chemotherapy period, thereafter, 480mg every 4 weeks(Q4W) during the maintenance treatment period
Intravenouslly (IV) l 800mg/m2 every 4 weeks ((on Day 1 through Day 5)during the combined chemotherapy period
Intravenouslly (IV) 80mg/m2 every 4 weeks (Q4W) during the combined chemotherapy period
Intravenouslly (IV) 240mg every 2 weeks (Q2W) during the combined chemotherapy period, 480mg every 4 weeks(Q4W) during the maintenance treatment period within 24 weeks, thereafter converted to LY01015 480mg every 4 weeks(Q4W).
Sun Yat-sen University Cancer Center
Guangzhou, China
RECRUITINGObjective Response Rate(ORR) as assessed by IRC
Time frame: from baseline to week 16
Objective Response Rate(ORR) as assessed by IRC and investigator
Time frame: from baseline to week 24
Disease Control Rate (DCR)
Time frame: up to 2 years
Duration of Response (DOR)
Time frame: up to 2 years
Progression-Free Survival (PFS)
Time frame: up to 2 years
16-week Progression-Free Survival Rate
Time frame: from baseline to week 16
24-week Progression-Free Survival Rate
Time frame: from baseline to week 16
Overall Survival (OS)
Time frame: up to 2 years
Incidence and severity of adverse effects (AEs)
Time frame: up to 2 years
Incidence of Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (Nab)
Time frame: up to 2 years
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