A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With Advanced HCC
Key facts
- Where
- Beijing, Changsha, Chengdu, Chongqing, Fuzhou, Guangzhou, Hangzhou, Harbin, Huzhou, Jinhua, Karamay, Nanchang, Ningbo, Shanghai, Shenyang, Tianjin és Wuhan, KínaSee the 23 sites
- Phase
- 2. fázis
Where in Kína
- Beijing Cancer HospitalBeijing, KínaNo longer taking part
- Cancer Hospital, Chinese Academy of Medical SciencesBeijing, KínaNo longer taking part
- Hunan Cancer HospitalChangsha, KínaNo longer taking part
- West China Hospital，Sichuan UniversityChengdu, KínaNo longer taking part
- Chongqing Three Gorges Central HospitalChongqing, KínaNo longer taking part
- Fujian Cancer HospitalFuzhou, KínaNo longer taking part
- Mengchao Hepatobiliary Hospital of Fujian Medical UniversityFuzhou, KínaNo longer taking part
- Nanfang Hospital of Southern Medical UniversityGuangzhou, KínaNo longer taking part
- The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, KínaNo longer taking part
- Zhejiang Provincial Peoples HospitalHangzhou, KínaNo longer taking part
- Zhejiang University College of Medicine Second Affiliated HospitalHangzhou, KínaNo longer taking part
- Harbin Medical University Cancer HospitalHarbin, KínaNo longer taking part
- Huzhou Central HospitalHuzhou, KínaNo longer taking part
- Jinhua Municipal Central HospitalJinhua, KínaNo longer taking part
- Karamay Central Hospital of XinjiangKaramay, KínaNo longer taking part
- The Second Affiliated Hospital of Nanchang UniversityNanchang, KínaNo longer taking part
- Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)Ningbo, KínaNo longer taking part
- Affiliated Zhongshan Hospital of Fudan UniversityShanghai, KínaNo longer taking part
- Shengjing Hospital Of China Medical UniversityShenyang, KínaNo longer taking part
- The First Hospital of China Medical UniversityShenyang, KínaNo longer taking part
- Tianjin Medical University Cancer Institute and HospitalTianjin, KínaNo longer taking part
- Tianjin Third Central HospitalTianjin, KínaNo longer taking part
- Hubei Cancer HospitalWuhan, KínaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BeiGene
- Trial code
- NCT04948697
- Record updated
- 2025. február 24.
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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.
Exclusion: 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; 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; Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology; Significant cardiovascular risk factors.
Criteria:.