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
- Diseases
- Liver and biliary tract cancer
- 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
Sites (28)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing Three Gorges Central Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Mengchao Hepatobiliary Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Nanfang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhejiang University College of Medicine Second Affiliated Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang Provincial Peoples Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Huzhou Central Hospital Coordinator of this site? Confirm its status | Huzhou | China | Unknown status |
| Jinhua Municipal Central Hospital Coordinator of this site? Confirm its status | Jinhua | China | Unknown status |
| Karamay Central Hospital of Xinjiang Coordinator of this site? Confirm its status | Karamay | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital) Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| Affiliated Zhongshan Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Tianjin Third Central Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Chi Mei Medical Center Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Linkou Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
Related publications
- AdvanTIG-206: a phase II, randomized study of ociperlimab plus tislelizumab and BAT1706 (bevacizumab biosimilar) versus tislelizumab and BAT1706 in first-line hepatocellular carcinoma.Cancer Immunol Immunother · 2026 · PMID 42047833
This page is information, not medical advice. Discuss any trial with your doctor.