A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Last updated: November 14, 2025
Sponsor: BeiGene
Overall Status: Active - Not Recruiting

Phase

2

Condition

Esophageal Cancer

Carcinoma

Squamous Cell Carcinoma

Treatment

LBL-007

Tislelizumab

Chemotherapy Doublet

Clinical Study ID

NCT06010303
BGB-A317-LBL-007-202
CTR20233227
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to provide written informed consent and can agree to comply with the studyrequirements.

  • 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

Exclusion Criteria:

  • Prior treatment for advanced or metastatic ESCC within the past 6 months

  • Locally advanced ESCC that is either resectable or potentially curable withdefinitive 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 otherimmune-oncological drugs

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 118
Treatment Group(s): 3
Primary Treatment: LBL-007
Phase: 2
Study Start date:
November 08, 2023
Estimated Completion Date:
May 23, 2026

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui 230000
    China

    Site Not Available

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230000
    China

    Site Not Available

  • Anhui Provincial Hospital

    Hefei 1808722, Anhui 1818058 230000
    China

    Site Not Available

  • The First Affiliated Hospital of Anhui Medical University

    Hefei 1808722, Anhui 1818058 230000
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing 1816670, Beijing Municipality 2038349 100730
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou 1810821, Fujian 1811017 350014
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou 1810821, Fujian 1811017 350001
    China

    Site Not Available

  • Lanzhou University Second Hospital

    Lanzhou, Gansu 730030
    China

    Site Not Available

  • Lanzhou University Second Hospital

    Lanzhou 1804430, Gansu 1810676 730030
    China

    Site Not Available

  • The Tumor Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi 530021
    China

    Site Not Available

  • The Tumor Hospital Affiliated to Guangxi Medical University

    Nanning 1799869, Guangxi 1809867 530021
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin 2037013, Heilongjiang 2036965 150000
    China

    Site Not Available

  • Anyang Cancer Hospital

    Anyang, Henan 455001
    China

    Site Not Available

  • Nanyang Central Hospital

    Nanyang, Henan 473000
    China

    Site Not Available

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan 453100
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Anyang Cancer Hospital

    Anyang 1785294, Henan 1808520 455001
    China

    Site Not Available

  • Nanyang Central Hospital

    Nanyang 1799629, Henan 1808520 473000
    China

    Site Not Available

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang 1788572, Henan 1808520 453100
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou 1784658, Henan 1808520 450000
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou 1784658, Henan 1808520 450052
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha 1815577, Hunan 1806691 410013
    China

    Site Not Available

  • The First Peoples Hospital of Changzhou

    Changzhou, Jiangsu 213000
    China

    Site Not Available

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • Nantong Tumor Hospital Branch North

    Nantong, Jiangsu 226000
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • The First Peoples Hospital of Changzhou

    Changzhou 1815456, Jiangsu 1806260 213000
    China

    Site Not Available

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing 1799962, Jiangsu 1806260 210008
    China

    Site Not Available

  • Nantong Tumor Hospital Branch North

    Nantong 1799722, Jiangsu 1806260 226000
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou 10630003, Jiangsu 1806260 221000
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia 750004
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan 1786657, Ningxia 1799355 750004
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan 1805753, Shandong 1796328 250117
    China

    Site Not Available

  • The Second Affiliated Hospital of Shandong First Medical University

    Taian, Shandong 1796328 271099
    China

    Site Not Available

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan 610071
    China

    Site Not Available

  • Sichuan Cancer Hospital and Institute

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu 1815286, Sichuan 1794299 610071
    China

    Site Not Available

  • Sichuan Cancer Hospital and Institute

    Chengdu 1815286, Sichuan 1794299 610041
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin 1792947, Tianjin Municipality 1792943 300060
    China

    Site Not Available

  • National Cancer Center

    Goyangsi, Gyeonggi-do 10408
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon, Incheon Gwang'yeogsi 21565
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    HwasunGun, Jeollanam-do 58128
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasungun, Jeonranamdo 58128
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul, Seoul Teugbyeolsi 08308
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St Marys Hospital

    Seoul, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyang-si 1842485, Gyeonggi-do 1841610 10408
    South Korea

    Site Not Available

  • Chonnam National University Hwasun Hospital

    HwasunGun, Jeollanam-do 1845788 58128
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, Seoul Teugbyeolsi 03080
    South Korea

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul 1835848, Seoul Teugbyeolsi 03722
    South Korea

    Site Not Available

  • The Catholic University of Korea, Seoul St Marys Hospital

    Seoul 1835848, Seoul Teugbyeolsi 06591
    South Korea

    Site Not Available

  • Changhua Christian Hospital

    Changhua, 50006
    Taiwan

    Site Not Available

  • Changhua Christian Hospital

    Changhua 1993459, 50006
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City 1673820, 807
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung 1668399, 40447
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10048
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei 1668341, 10048
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei 1668341, 11217
    Taiwan

    Site Not Available

  • Ramathibodi Hospital Mahidol University

    Bangkok, 10400
    Thailand

    Site Not Available

  • Siriraj Hospital

    Bangkok, 10700
    Thailand

    Site Not Available

  • Ramathibodi Hospital Mahidol University

    Bangkok 1609350, 10400
    Thailand

    Site Not Available

  • Siriraj Hospital

    Bangkok 1609350, 10700
    Thailand

    Site Not Available

  • Songklanagarind Hospital (Prince of Songkhla University)

    Hat Yai, 90110
    Thailand

    Site Not Available

  • Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)

    Ongkharak, 26120
    Thailand

    Site Not Available

  • Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)

    Ongkharak 1608080, 26120
    Thailand

    Site Not Available

  • Phramongkutklao Hospital

    Ratchathewi, 10400
    Thailand

    Site Not Available

  • Phramongkutklao Hospital

    Ratchathewi 7026885, 10400
    Thailand

    Site Not Available

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