Clinical trial · Observational
Use of Immune Checkpoint Inhibitors in Patients With Advanced Hepatocellular Carcinoma : Efficacy and Outcomes
- 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)
the Objectives of this study are: • Primary Objective: To prospectively evaluate overall survival (OS), ICI-specific survival (OS-ICI), and progression-free survival (PFS) in patients with advanced HCC treated with immune checkpoint inhibitors. the main question it aims to answer is: What are the clinical outcomes (overall survival, progression-free survival, and OS-ICIs) of immune checkpoint inhibitor therapy in patients with advanced hepatocellular carcinoma? Participants already taking immune checkpoint inhibitors as part of their regular medical care.
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 (HCC) | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- all patients diagnosed with advanced hepatocellular carcinoma eligible for ICIs
Primary outcomes (1)
- measure
- ICI-Specific Survival (OS-ICI).
- timeFrame
- 12 months
- description
- Time from ICI initiation to death or last follow-up.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults (≥18 years) with radiologically or histologically confirmed advanced HCC * Candidates for systemic immune checkpoint inhibitors (e.g., atezolizumab-bevacizumab, durvalumab-tremelimumab). * Patients with preserved liver function. ( up to G2 using ALBI score or up to B (7 ) using Child-Pugh socring system) . Exclusion Criteria: * Child-Pugh C liver function. * Prior liver transplantation. * patients with concurrent malignancies other than HCC. * Active autoimmune disease requiring systemic immunosuppression.
References
Publications (10)
- BACKGROUND10. Cheng, A. L., Rimassa, L., Ducreux, M., et al. (2022). J Hepatol, 76, 862-873.
- BACKGROUND9. Yau, T., Cheng, A. L., Rimassa, L., et al. (2025). Lancet, 405, 1851-1864.
- BACKGROUND8. Llovet, J. M., Yau, T., Cheng, A. L., et al. (2008). N Engl J Med, 359, 378-390.
- BACKGROUND7. Reig, M., Llovet, J. M., Yau, T., et al. (2021). J Hepatol, 76, 681-693.
- BACKGROUND6. Singal, A. G., Reig, M., Llovet, J. M., et al. (2023). Hepatology, 78, 1922-1965.
- BACKGROUNDEl-Serag HB. Hepatocellular carcinoma: recent trends in the United States. Gastroenterology. 2004 Nov;127(5 Suppl 1):S27-34. doi: 10.1053/j.gastro.2004.09.013. PMID 15508094
- BACKGROUNDKalligeros M, Henry L, Younossi ZM. Metabolic dysfunction-associated steatotic liver disease and its link to cancer. Metabolism. 2024 Nov;160:156004. doi: 10.1016/j.metabol.2024.156004. Epub 2024 Aug 23. PMID 39182603
- BACKGROUND3. Liu, Y., Kalligeros, M., El-Serag, H. B., et al. (2022). Cancer Med, 11, 1310-1323.
- BACKGROUND2. McGlynn, K. A., Liu, Y., Kalligeros, M., et al. (2021). Hepatology, 73, 4-13.
- BACKGROUND1. Siegel, R. L., McGlynn, K. A., Liu, Y., et al. (2024). CA Cancer J Clin, 74, 12-49.