Use of Immune Checkpoint Inhibitors in Patients With Advanced Hepatocellular Carcinoma : Efficacy and Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Advanced Hepatocellular Carcinoma (HCC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
Objectives • 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.
• Secondary Objectives: To assess the incidence, type, and severity of irAEs. To identify clinical predictors of survival outcomes, including ALBI grade, prior LRT, SBRT or resection.
To guide personalized therapy for Tailoring immunotherapy to individual patients, reducing unnecessary toxicity and cost.
Primary outcome measures
- ICI-Specific Survival (OS-ICI). [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 2 centers
- Sohag university hospitals — Sohag
- sSohag oncology centre — Sohag
Publications
- 10. Cheng, A. L., Rimassa, L., Ducreux, M., et al. (2022). J Hepatol, 76, 862-873.
- 9. Yau, T., Cheng, A. L., Rimassa, L., et al. (2025). Lancet, 405, 1851-1864.
- 8. Llovet, J. M., Yau, T., Cheng, A. L., et al. (2008). N Engl J Med, 359, 378-390.
- 7. Reig, M., Llovet, J. M., Yau, T., et al. (2021). J Hepatol, 76, 681-693.
- 6. Singal, A. G., Reig, M., Llovet, J. M., et al. (2023). Hepatology, 78, 1922-1965.
- El-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
- Kalligeros 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
- 3. Liu, Y., Kalligeros, M., El-Serag, H. B., et al. (2022). Cancer Med, 11, 1310-1323.
Identifiers
NCT: NCT07321067 · Soh-Med--25-12-8MD