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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20233227 | Registry Identifier | ChinaDrugTrials |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBL-007 | Experimental | LBL-007 in combination with tislelizumab plus chemotherapy doublet. |
|
| Tislelizumab and Chemotherapy | Active Comparator | Tislelizumab plus chemotherapy doublet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBL-007 | Drug | LBL-007 will be administered at a standard dose intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 18 months |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | 230000 | China | ||
| The First Affiliated Hospital of Anhui Medical University |
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.
See plan description
See plan description
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| Tislelizumab | Drug | Tislelizumab will be administered at a standard dose intravenously. |
|
|
| Chemotherapy Doublet | Drug | 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. |
|
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. |
| 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. | 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. | Approximately 18 months |
| Hefei |
| Anhui |
| 230000 |
| China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| Lanzhou University Second Hospital | Lanzhou | Gansu | 730030 | China |
| The Tumor Hospital Affiliated to Guangxi Medical University | Nanning | Guangxi | 530021 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| Anyang Cancer Hospital | Anyang | Henan | 455001 | China |
| Nanyang Central Hospital | Nanyang | Henan | 473000 | China |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | 453100 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| The First Peoples Hospital of Changzhou | Changzhou | Jiangsu | 213000 | China |
| Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
| Nantong Tumor Hospital Branch North | Nantong | Jiangsu | 226000 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750004 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| The Second Affiliated Hospital of Shandong First Medical University | Taian | Shandong | 271099 | China |
| Sichuan Cancer Hospital and Institute | Chengdu | Sichuan | 610041 | China |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital | Chengdu | Sichuan | 610071 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Chonnam National University Hwasun Hospital | HwasunGun | Jeollanam-do | 58128 | South Korea |
| Seoul National University Hospital | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| The Catholic University of Korea, Seoul St Marys Hospital | Seoul | Seoul Teugbyeolsi | 06591 | South Korea |
| Changhua Christian Hospital | Changhua | 50006 | Taiwan |
| Kaohsiung Medical University Chung Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Ramathibodi Hospital Mahidol University | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University) | Ongkharak | 26120 | Thailand |
| Phramongkutklao Hospital | Ratchathewi | 10400 | Thailand |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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