A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC
NCT ID: NCT04948697
Last Updated: 2025-02-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
94 participants
INTERVENTIONAL
2021-08-20
2024-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Ociperlimab + Tislelizumab + BAT1706
Participants received tislelizumab 200 milligrams (mg) intravenously once every 3 weeks followed by BAT1706 15 milligrams per kilogram (mg/kg) intravenously once every 3 weeks followed by ociperlimab 900 mg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Ociperlimab
900 mg intravenously once every 3 weeks (dosed in 21-day cycles)
Tislelizumab
200 mg intravenously once every 3 weeks (dosed in 21-day cycles)
BAT1706
15 mg/kg intravenously once every 3 weeks (dosed in 21-day cycles)
Arm B: Tislelizumab + BAT1706
Participants received tislelizumab 200 mg intravenously once every 3 weeks followed by BAT1706 15 mg/kg intravenously once every 3 weeks in 21-day treatment cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Tislelizumab
200 mg intravenously once every 3 weeks (dosed in 21-day cycles)
BAT1706
15 mg/kg intravenously once every 3 weeks (dosed in 21-day cycles)
Interventions
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Ociperlimab
900 mg intravenously once every 3 weeks (dosed in 21-day cycles)
Tislelizumab
200 mg intravenously once every 3 weeks (dosed in 21-day cycles)
BAT1706
15 mg/kg intravenously once every 3 weeks (dosed in 21-day cycles)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Barcelona Clinic Liver Cancer (BCLC) Stage C disease, or BCLC Stage B disease that was not amenable to or had progressed after loco-regional therapy, and was not amenable to a curative treatment approach
3. Tumor tissue required for an evaluable programmed cell death protein-ligand 1 (PD-L1) expression result
4. No prior systemic therapy for HCC
5. At least 1 measurable lesion as defined per RECIST v1.1
6. Adequate organ function during screening and before randomization
Exclusion Criteria
2. Prior therapy with antibody or drug specifically targeting T-cell costimulation or checkpoint pathway; prior treatment with bevacizumab or its biosimilars
3. Prior history of \>= Grade 2 hepatic encephalopathy
4. Leptomeningeal disease or uncontrolled, untreated brain metastasis
5. Active autoimmune diseases or history of autoimmune diseases that may relapse
6. History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases
7. Infection (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days of randomization
8. Prior allogeneic stem cell transplantation or organ transplantation
9. Significant cardiovascular risk factors
10. Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding
11. History of severe hypersensitivity reactions to other monoclonal antibodies
12. Administered a live vaccine \<=28 days before randomization
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, China
Karamay Central Hospital of Xinjiang
Karamay, Xinjiang, China
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)
Ningbo, Zhejiang, China
National Cheng Kung University Hospital
Tainan City, , Taiwan
Chi Mei Medical Center
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CTR20211546
Identifier Type: REGISTRY
Identifier Source: secondary_id
AdvanTIG-206
Identifier Type: -
Identifier Source: org_study_id
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