drugset / Trial / NCT06022861
A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2023-10-12
- Primary completion
- 2025-06
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LY01015 | Unknown | 480 mg | Intravenous |
| Comparator | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Background | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 800 mg/m2 | Intravenous |