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
2 other identifiers
interventional
118
4 countries
38
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 in participants with inoperable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2023
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2023
CompletedFirst Posted
Study publicly available on registry
August 24, 2023
CompletedStudy Start
First participant enrolled
November 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2026
ExpectedNovember 17, 2025
November 1, 2025
1.6 years
August 21, 2023
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
Percentage of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.
Approximately 10 months
Secondary Outcomes (4)
Progression Free Survival (PFS)
Approximately 18 months
Duration of Response (DOR)
Approximately 18 months
Disease Control Rate (DCR)
Approximately 18 months
Number of Participants with Adverse Events (AEs)
Approximately 18 months
Study Arms (2)
LBL-007
EXPERIMENTALLBL-007 in combination with tislelizumab plus chemotherapy doublet.
Tislelizumab and Chemotherapy
ACTIVE COMPARATORTislelizumab plus chemotherapy doublet.
Interventions
LBL-007 will be administered at a standard dose intravenously.
Tislelizumab will be administered at a standard dose intravenously.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (38)
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530021, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Anyang Cancer Hospital
Anyang, Henan, 455001, China
Nanyang Central Hospital
Nanyang, Henan, 473000, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, 213000, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Nantong Tumor Hospital Branch North
Nantong, Jiangsu, 226000, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, 271099, China
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, 610041, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Chonnam National University Hwasun Hospital
HwasunGun, Jeollanam-do, 58128, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
Seoul, Seoul Teugbyeolsi, 06591, South Korea
Changhua Christian Hospital
Changhua, 50006, Taiwan
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Ramathibodi Hospital Mahidol University
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)
Ongkharak, 26120, Thailand
Phramongkutklao Hospital
Ratchathewi, 10400, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2023
First Posted
August 24, 2023
Study Start
November 8, 2023
Primary Completion
May 30, 2025
Study Completion (Estimated)
May 23, 2026
Last Updated
November 17, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.