Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Patients With Colorectal Cancer
NCT ID: NCT05116085
Last Updated: 2025-03-13
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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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2022-01-26
2025-01-03
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
Tislelizumab administered intravenously before surgery during the neo-adjuvant phase
Tislelizumab
Administered intravenously
Interventions
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Tislelizumab
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Pathologically (histologically) confirmed diagnosis of potentially resectable Stage II or Stage III Colon/Rectal Cancer (CRC) with MSI-H confirmed by sponsor designated central laboratory or known MSI-H status by local laboratory. Participants should be eligible for an R0 resection with curative intent.
3. Evaluable or measurable disease as assessed by the investigator per RECIST v1.1.
4. Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained within 7 days before first dose.
Exclusion Criteria
2. Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose.
3. Active autoimmune diseases or history of autoimmune diseases that may relapse.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University Branch South
Qingdao, Shandong, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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CTR20212779
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-A317-214
Identifier Type: -
Identifier Source: org_study_id
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