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RECRUITING
NCT07733180
PHASE2

A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC

Sponsor: BeOne Medicines

View on ClinicalTrials.gov

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

DRUG

Tislelizumab

Administered by intravenous infusion

DRUG

Oxaliplatin

Administered by intravenous infusion

DRUG

Leucovorin

Administered by intravenous infusion

DRUG

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