Esophageal CancerPhase 2NCT06010303
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 study testing LBL-007, Tislelizumab and Chemotherapy Doublet in people with Esophageal Cancer and Esophageal Squamous Cell Carcinoma, run by BeiGene at 38 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Esophageal Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma by AJCC V8 Stage
- What is being tested?
- LBL-007, Tislelizumab and Chemotherapy Doublet
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 38 sitesin 4 countries
- Study dates
- 8 Nov 2023to 7 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
38 sites in 4 countries.
38 sites in 4 countries
China24 sites
Anyang Cancer Hospital
Anyang, Henan, 455001
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Hunan Cancer Hospital
Changsha, Hunan, 410013
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, 213000
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, 610041
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Anhui Provincial Hospital
Hefei, Anhui, 230000
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
Shandong Cancer Hospital
Jinan, Shandong, 250117
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530021
Nantong Tumor Hospital Branch North
Nantong, Jiangsu, 226000
Nanyang Central Hospital
Nanyang, Henan, 473000
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, 271099
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Henan Cancer Hospital
Zhengzhou, Henan, 450000
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
South Korea5 sites
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Chonnam National University Hwasun Hospital
HwasunGun, Jeollanam-do, 58128
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722
The Catholic University of Korea, Seoul St Marys Hospital
Seoul, Seoul Teugbyeolsi, 06591
Taiwan5 sites
Changhua Christian Hospital
Changhua, 50006
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 807
China Medical University Hospital
Taichung, 40447
National Taiwan University Hospital
Taipei, 10048
Taipei Veterans General Hospital
Taipei, 11217
Thailand4 sites
Ramathibodi Hospital Mahidol University
Bangkok, 10400
Siriraj Hospital
Bangkok, 10700
Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)
Ongkharak, 26120
Phramongkutklao Hospital
Ratchathewi, 10400
About this study
Official title: 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
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).
- Conditions
- Esophageal Cancer, Esophageal Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma by AJCC V8 Stage
- Being tested
- LBL-007, Tislelizumab, Chemotherapy Doublet
- Medical subject headings
- Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBL-007Drug
Also called Alcestobart
LBL-007 will be administered at a standard dose intravenously.
TislelizumabDrug
Also called BGB-A317
Tislelizumab will be administered at a standard dose intravenously.
Chemotherapy DoubletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| LBL-007 | Experimental | LBL-007 in combination with tislelizumab plus chemotherapy doublet. Receives: Drug: LBL-007; Drug: Tislelizumab; Drug: Chemotherapy Doublet |
| Tislelizumab and Chemotherapy | Active comparator | Tislelizumab plus chemotherapy doublet. Receives: Drug: Tislelizumab; Drug: Chemotherapy Doublet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 10 months
Secondary outcomes (4)
Progression Free Survival (PFS)
Time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first.
Measured: Approximately 18 months
Duration of Response (DOR)
Time from the first determination of an overall response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first.
Measured: Approximately 18 months
Disease Control Rate (DCR)
Percentage of participants whose BOR is CR, PR, and stable disease as assessed by the investigator per RECIST v1.1.
Measured: Approximately 18 months
Number of Participants with Adverse Events (AEs)
Number of participants with AEs, including findings from physical examinations, electrocardiograms, and laboratory assessments according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Measured: Approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start8 Nov 2023
- Primary completion30 May 2025
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010303
- Sponsor's protocol ID
- BGB-A317-LBL-007-202
- Other IDs
- CTR20233227
- Status last verified
- May 2026
- First submitted
- 21 Aug 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06010303
- Acronym / sponsor ID
- BGB-A317-LBL-007-202
- Conditions
- Esophageal Cancer, Esophageal Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma by AJCC V8 Stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBL-007 | Experimental | Drug: LBL-007, Drug: Tislelizumab, Drug: Chemotherapy DoubletLBL-007 in combination with tislelizumab plus chemotherapy doublet. |
| Tislelizumab and Chemotherapy | Active comparator | Drug: Tislelizumab, Drug: Chemotherapy DoubletTislelizumab plus chemotherapy doublet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LBL-007Also: AlcestobartLBL-007 will be administered at a standard dose intravenously. | Drug | LBL-007 |
| TislelizumabAlso: BGB-A317Tislelizumab will be administered at a standard dose intravenously. | Drug | LBL-007, Tislelizumab and Chemotherapy |
| Chemotherapy DoubletDoublet 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. | Drug | LBL-007, Tislelizumab and Chemotherapy |
Primary outcome
Overall Response Rate (ORR)
Time frame: Approximately 10 months
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.
4 secondary outcomes
Progression Free Survival (PFS)
Time frame: Approximately 18 months
Duration of Response (DOR)
Time frame: Approximately 18 months
Disease Control Rate (DCR)
Time frame: Approximately 18 months
Number of Participants with Adverse Events (AEs)
Time frame: Approximately 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Esophageal Cancer
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
RecruitingPhase 2
A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC
Advanced Esophageal Squamous Cell Carcinoma, Metastatic Esophageal Squamous Cell Carcinoma
RecruitingPhase 1/2
A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors
Locally Advanced or Metastatic Solid Tumors
Active, not recruitingPhase 1
A Study of KK2269 in Adult Participants With Solid Tumors
Advanced Solid Tumor, Metastatic Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
BeiGene
38 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LBL-007, Tislelizumab and Chemotherapy Doublet in people with Esophageal Cancer and Esophageal Squamous Cell Carcinoma, run by BeiGene at 38 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in China, South Korea, Taiwan, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Approximately 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.