A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
NCT ID: NCT06010303
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
118 participants
INTERVENTIONAL
2023-11-08
2026-05-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LBL-007
LBL-007 in combination with tislelizumab plus chemotherapy doublet.
LBL-007
LBL-007 will be administered at a standard dose intravenously.
Tislelizumab
Tislelizumab will be administered at a standard dose intravenously.
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.
Tislelizumab and Chemotherapy
Tislelizumab plus chemotherapy doublet.
Tislelizumab
Tislelizumab will be administered at a standard dose intravenously.
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.
Interventions
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LBL-007
LBL-007 will be administered at a standard dose intravenously.
Tislelizumab
Tislelizumab will be administered at a standard dose intravenously.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Anyang Cancer Hospital
Anyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Nantong Tumor Hospital Branch North
Nantong, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Shandong Cancer Hospital
Jinan, Shandong, China
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, China
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
HwasunGun, Jeollanam-do, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Changhua Christian Hospital
Changhua, , Taiwan
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Ramathibodi Hospital Mahidol University
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)
Ongkharak, , Thailand
Phramongkutklao Hospital
Ratchathewi, , Thailand
Countries
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Other Identifiers
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CTR20233227
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-A317-LBL-007-202
Identifier Type: -
Identifier Source: org_study_id
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