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NCT06010303CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 28 May 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
118 (actual)
First submitted
21 Aug 2023
Start date
8 Nov 2023
Primary completion date
30 May 2025
Lead sponsor
BeiGene
NCT number
NCT06010303

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 118
  • From 8 Nov 2023 to the primary completion date, 30 May 2025
  • 38 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Prior treatment with programmed cell death protein-1 (PD-1) or other immune-oncological drugs
    • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Other illness

  • Participants with an esophageal/bronchial or esophageal/aorta fistula

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Anyang Cancer Hospital
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AnyangChinaUnknown status
Peking Union Medical College Hospital
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BeijingChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
The First Peoples Hospital of Changzhou
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ChangzhouChinaUnknown status
Sichuan Cancer Hospital and Institute
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ChengduChinaUnknown status
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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ChengduChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
Fujian Cancer Hospital
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FuzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Anhui Provincial Hospital
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HefeiChinaUnknown status
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaUnknown status
Shandong Cancer Hospital
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JinanChinaUnknown status
Lanzhou University Second Hospital
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LanzhouChinaUnknown status
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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NanjingChinaUnknown status
The Tumor Hospital Affiliated to Guangxi Medical University
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NanningChinaUnknown status
Nantong Tumor Hospital Branch North
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NantongChinaUnknown status
Nanyang Central Hospital
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NanyangChinaUnknown status
The Second Affiliated Hospital of Shandong First Medical University
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TaianChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaUnknown status
The First Affiliated Hospital of Xinxiang Medical University
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XinxiangChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status
General Hospital of Ningxia Medical University
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YinchuanChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
National Cancer Center
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Goyang-siSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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HwasunGunSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Siriraj Hospital
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BangkokThailandUnknown status
Ramathibodi Hospital, Mahidol University
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BangkokThailandUnknown status
Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)
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OngkharakThailandUnknown status
Phramongkutklao Hospital
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RatchathewiThailandUnknown status
Changhua Christian Hospital
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ChanghuaTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.