Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BAT1706 | Drug | Bevacizumab | ALIAS |
| Ociperlimab | Drug | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Ociperlimab + Tislelizumab + BAT1706
- description
- 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.
- interventionNames
- Drug: Ociperlimab
- Drug: Tislelizumab
- Drug: BAT1706
- type
- EXPERIMENTAL
- label
- Arm B: Tislelizumab + BAT1706
- description
- 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.
- interventionNames
- Drug: Tislelizumab
- Drug: BAT1706
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Criteria: Inclusion Criteria: 1. Histologically confirmed HCC 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: 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology 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 NOTE: Other protocol Inclusion/Exclusion criteria may apply
References
Publications (1)
- DERIVEDRen Z, Huang Y, Guo Y, Hou MM, Wang W, Kuang M, Hao C, Wang W, Zhang Y, Song T, Dai C, Kuo HT, Bao Z, Zuo Y, Wang L, Zhu F, Fan J. 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 Apr 28;75(5):158. doi: 10.1007/s00262-026-04399-8. PMID 42047833