Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Lead Sponsor:
BeiGene
Conditions:
Esophageal Cancer
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 i...
Eligibility Criteria
Inclusion
- Able to provide written informed consent and can agree to comply with the study requirements.
- Participants with metastatic ESCC or unresectable, locally advanced ESCC.
- Histologically confirmed diagnosis of ESCC.
- Can provide a tumor sample.
- At least 1 measurable lesion as defined by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
Exclusion
- Prior treatment for advanced or metastatic ESCC within the past 6 months
- Locally advanced ESCC that is either resectable or potentially curable with definitive chemoradiation treatment per local investigator
- Palliative radiation treatment for ESCC within the past 4 weeks
- Participants with an esophageal/bronchial or esophageal/aorta fistula
- Prior treatment with programmed cell death protein-1 (PD-1) or other immune-oncological drugs
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2026
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT06010303
Start Date
November 8 2023
End Date
May 23 2026
Last Update
November 17 2025
Active Locations (38)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230000
2
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
4
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001