Clinical Trial

A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Recruiting Phase 3
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Record status
This record was last updated September 19, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-08-28; most recent amendment 2024-09-11.
Status change: Not Yet Recruiting → Recruiting 2024-03-12
Trial Details
NCT Number NCT06022861
Lead Sponsor Shandong Boan Biotechnology Co., Ltd
Conditions Esophageal Squamous Cell Carcinoma
Enrollment 510 participants
Start Date 2023-10-12
Primary Completion 2025-06 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2024-09-19