drugset / Trial / NCT07733180
A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2026-09-14
- Primary completion
- 2028-02-28
- Completion
- 2028-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tislelizumab | Monoclonal antibody | 150 mg | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 300 mg | Intravenous |
| Background | 5-Fluorouracil (5-FU) | Small molecule | 400 mg/m2 | Intravenous |
| Background | 5-Fluorouracil (5-FU) | Small molecule | 2400 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |