Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors
NCT ID: NCT03736889
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2018-09-19
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tislelizumab (BGB-A317) Injection
Tislelizumab (BGB-A317)
Anti-PD-1 Antibody
Interventions
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Tislelizumab (BGB-A317)
Anti-PD-1 Antibody
Eligibility Criteria
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Inclusion Criteria
2. Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR
3. Having received prior cancer therapy regimen(s) for advanced disease.
4. At least 1 measurable lesion as defined per RECIST Version (v) 1.1
5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
6. Adequate organ function
Exclusion Criteria
2. Active leptomeningeal disease or uncontrolled brain metastasis.
3. Clinically significant pleural effusion, pericardial effusion or ascites
4. Active autoimmune diseases or history of autoimmune diseases that may relapse
5. Any active malignancy
6. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug
7. Having a history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases, or uncontrolled systemic diseases (including but not limited to diabetes, hypertension, etc.)
8. Participants with uncontrolled diabetes or uncontrolled electrolyte disorders despite standard medical management
9. Having severe chronic or active infections
10. A known history of human immunodeficiency virus infection
11. Child - Pugh B or greater cirrhosis
12. Any major surgical procedure ≤ 28 days before the first dose of study drug
13. Prior allogeneic stem cell transplantation or organ transplantation
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Lin Shen, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The Affiliated Hospital of Military Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, China
Huizhou First Hospital
Huizhou, Guangdong, China
Meizhou People Hospital
Meizhou, Guangdong, China
The Peoples Hospital of Hechi
Hechi, Guangxi, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
The General Hospital of Shenyang Military
Shenyang, Liaoning, China
Yidu Central Hospital of Weifang
Weifang, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
The First Peoples Hospital of Yibin
Yibin, Sichuan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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CTR20180867
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-A317-209
Identifier Type: -
Identifier Source: org_study_id