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
- Diseases
- Gastric and esophageal cancer
- 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
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anyang Cancer Hospital Coordinator of this site? Confirm its status | Anyang | China | Unknown status |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The First Peoples Hospital of Changzhou Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| Sichuan Cancer Hospital and Institute Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Lanzhou University Second Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The Tumor Hospital Affiliated to Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Nantong Tumor Hospital Branch North Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
| Nanyang Central Hospital Coordinator of this site? Confirm its status | Nanyang | China | Unknown status |
| The Second Affiliated Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Taian | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hospital of Xinxiang Medical University Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| General Hospital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | HwasunGun | South Korea | Unknown status |
| The Catholic University of Korea Seoul St Marys Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Ramathibodi Hospital, Mahidol University Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University) Coordinator of this site? Confirm its status | Ongkharak | Thailand | Unknown status |
| Phramongkutklao Hospital Coordinator of this site? Confirm its status | Ratchathewi | Thailand | Unknown status |
| Changhua Christian Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.