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

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of Jun 2025 to May 17, 2026 Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion moved earlier from Dec 2026 to Oct 30, 2026
    • Eligibility criteria expanded, about 18 words
    • Site details revised
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2023 to Oct 12, 2023
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06022861
Lead Sponsor Shandong Boan Biotechnology Co., Ltd
Conditions
(from sponsor)		 Esophageal Squamous Cell Carcinoma
Related terms Esophageal Squamous Cell Carcinoma
Enrollment 510 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov