A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
NCT06010303 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118
Last updated 2025-11-17
Summary
This is a randomized, open-label study to compare how well LBL-007 works in combination with tislelizumab and chemotherapy versus tislelizumab and chemotherapy when given as the first-line treatment in participants with inoperable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).
Conditions
- Esophageal Cancer
- Esophageal Squamous Cell Carcinoma
- Esophageal Squamous Cell Carcinoma by AJCC V8 Stage
Interventions
- DRUG
-
LBL-007
LBL-007 will be administered at a standard dose intravenously.
- DRUG
-
Tislelizumab
Tislelizumab will be administered at a standard dose intravenously.
- DRUG
-
Chemotherapy Doublet
Doublet 1: cisplatin + 5-fluorouracil Doublet 2: cisplatin + paclitaxel Choice of chemotherapy doublet will be determined by the investigator and will be administered at standard doses intravenously.
Sponsors & Collaborators
-
BeiGene
lead INDUSTRY
Principal Investigators
-
Study Director · BeiGene
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-08
- Primary Completion
- 2025-05-30
- Completion
- 2026-05-23
Countries
- China
- South Korea
- Taiwan
- Thailand
Study Locations
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