A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC
A Phase 2, Randomized, Open-labeled Clinical Study Investigating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab Plus BAT1706 and of Tislelizumab Plus BAT1706 as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
2 other identifiers
interventional
94
2 countries
28
Brief Summary
This was a Phase 2, randomized, multicenter, open-label, 2-arm study to investigate the efficacy and safety of ociperlimab in combination with tislelizumab plus BAT1706, and tislelizumab plus BAT1706, as first-line treatment in participants with advanced Hepatocellular Carcinoma (HCC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2021
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2021
CompletedFirst Posted
Study publicly available on registry
July 2, 2021
CompletedStudy Start
First participant enrolled
August 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedResults Posted
Study results publicly available
February 24, 2025
CompletedFebruary 24, 2025
January 1, 2025
2.5 years
June 20, 2021
January 30, 2025
February 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) as Assessed by the Investigator
ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors version(v) 1.1 (RECIST v1.1). Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)
Secondary Outcomes (11)
Duration Of Response (DOR) as Assessed by the Investigator
From the first confirmed objective response until the first documentation of disease progression or death, whichever came first (i.e. up to 27 months)
Time to Response (TTR) as Assessed by the Investigator
From the randomization date to the first documentation of response (up to 27 months)
Disease Control Rate (DCR) as Assessed by the Investigator
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)
Clinical Benefit Rate (CBR) as Assessed by the Investigator
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (i.e., up to 27 months)
Progression-Free Survival (PFS) as Assessed by the Investigator
From the randomization date to the date of first documentation of disease progression or death, whichever came first (i.e., up to 27 months)
- +6 more secondary outcomes
Study Arms (2)
Arm A: Ociperlimab + Tislelizumab + BAT1706
EXPERIMENTALParticipants 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.
Arm B: Tislelizumab + BAT1706
EXPERIMENTALParticipants 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.
Interventions
900 mg intravenously once every 3 weeks (dosed in 21-day cycles)
200 mg intravenously once every 3 weeks (dosed in 21-day cycles)
15 mg/kg intravenously once every 3 weeks (dosed in 21-day cycles)
Eligibility Criteria
You may qualify if:
- Histologically confirmed HCC
- 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
- Tumor tissue required for an evaluable programmed cell death protein-ligand 1 (PD-L1) expression result
- No prior systemic therapy for HCC
- At least 1 measurable lesion as defined per RECIST v1.1
- Adequate organ function during screening and before randomization
You may not qualify if:
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
- Prior therapy with antibody or drug specifically targeting T-cell costimulation or checkpoint pathway; prior treatment with bevacizumab or its biosimilars
- Prior history of \>= Grade 2 hepatic encephalopathy
- Leptomeningeal disease or uncontrolled, untreated brain metastasis
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases
- Infection (including tuberculosis) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days of randomization
- Prior allogeneic stem cell transplantation or organ transplantation
- Significant cardiovascular risk factors
- Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Administered a live vaccine \<=28 days before randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (28)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, 404000, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025, China
The First Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, 510080, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 300170, China
Karamay Central Hospital of Xinjiang
Karamay, Xinjiang, 834009, China
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, 310009, China
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, 310014, China
Huzhou Central Hospital
Huzhou, Zhejiang, 313003, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000, China
Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)
Ningbo, Zhejiang, 315000, China
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Chi Mei Medical Center
Tainan, 710, Taiwan
National Taiwan University Hospital
Taipei, 100225, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, 33305, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2021
First Posted
July 2, 2021
Study Start
August 20, 2021
Primary Completion
February 1, 2024
Study Completion
February 1, 2024
Last Updated
February 24, 2025
Results First Posted
February 24, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share