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NCT04948697CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 24 Feb 2025

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
94 (actual)
First submitted
20 Jun 2021
Start date
20 Aug 2021
Primary completion date
1 Feb 2024
Lead sponsor
BeiGene
NCT number
NCT04948697

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 94
  • From 20 Aug 2021 to the primary completion date, 1 Feb 2024
  • 28 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Prior allogeneic stem cell transplantation or organ transplantation
  • Administered a live vaccine \<=28 days before randomization
    • NOTE: Other protocol Inclusion/Exclusion criteria may apply

Other illness

  • 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
  • Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding
  • History of severe hypersensitivity reactions to other monoclonal antibodies

Other

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
  • Significant cardiovascular risk factors

Who the study is looking for

  • 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

Criteria the registry did not label

  • Criteria:

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (28)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Beijing Cancer Hospital
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BeijingChinaUnknown status
Cancer Hospital, Chinese Academy of Medical Sciences
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BeijingChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Chongqing Three Gorges Central Hospital
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ChongqingChinaUnknown status
Fujian Cancer Hospital
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FuzhouChinaUnknown status
Mengchao Hepatobiliary Hospital of Fujian Medical University
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FuzhouChinaUnknown status
Nanfang Hospital of Southern Medical University
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GuangzhouChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Zhejiang University College of Medicine Second Affiliated Hospital
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HangzhouChinaUnknown status
Zhejiang Provincial Peoples Hospital
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Huzhou Central Hospital
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HuzhouChinaUnknown status
Jinhua Municipal Central Hospital
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JinhuaChinaUnknown status
Karamay Central Hospital of Xinjiang
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KaramayChinaUnknown status
The Second Affiliated Hospital of Nanchang University
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NanchangChinaUnknown status
Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)
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NingboChinaUnknown status
Affiliated Zhongshan Hospital of Fudan University
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ShanghaiChinaUnknown status
Shengjing Hospital Of China Medical University
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ShenyangChinaUnknown status
The First Hospital of China Medical University
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ShenyangChinaUnknown status
Tianjin Third Central Hospital
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TianjinChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaUnknown status
Hubei Cancer Hospital
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WuhanChinaUnknown status
Chi Mei Medical Center
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TainanTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Linkou Chang Gung Memorial Hospital
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TaoyuanTaiwanUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.