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A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC
Sponsor: BeOne Medicines
Summary
The purpose of this study is to evaluate the pharmacokinetic (PK) profile, safety, and efficacy of tislelizumab administered once every 2 weeks (Q2W) or once every 4 weeks (Q4W) in combination with chemotherapy as first-line treatment in Japanese participants with previously untreated, unresectable locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC).
Official title: A Phase 2 Study of Tislelizumab Administered With Alternative Dosing Schedules Plus Chemotherapy as First-line Treatment in Japanese Patients With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-09-14
Completion Date
2028-02-28
Last Updated
2026-10-26
Healthy Volunteers
No
Interventions
Tislelizumab
Administered by intravenous infusion
Oxaliplatin
Administered by intravenous infusion
Leucovorin
Administered by intravenous infusion
5-fluorouracil (5-FU)
Administered by intravenous infusion
Locations (4)
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsukishi, Osaka, Japan
National Cancer Center Hospital
ChuoKu, Tokyo, Japan
Osaka Keisatsu Hospital
Osaka, Japan