Trials / Active Not Recruiting
Active Not RecruitingNCT06010303
A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
A Phase 2, Randomized, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of LBL-007 in Combination With Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 118 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-11-08
- Primary completion
- 2025-05-30
- Completion
- 2026-05-23
- First posted
- 2023-08-24
- Last updated
- 2025-11-17
Locations
38 sites across 4 countries: China, South Korea, Taiwan, Thailand
Source: ClinicalTrials.gov record NCT06010303. Inclusion in this directory is not an endorsement.