A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma
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 Advanced or Metastatic Esophageal Squamous Cell Carcinoma.
Shandong Boan Biotechnology Co., Ltd
510 participants
Oct 12, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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).
Locations(1)
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NCT06022861