Use of Immune Checkpoint Inhibitors in Patients With Advanced Hepatocellular Carcinoma : Efficacy and Outcomes
NCT ID: NCT07321067
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
75 participants
OBSERVATIONAL
2026-01-01
2027-11-01
Brief Summary
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• 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.
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Detailed Description
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• 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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all patients diagnosed with advanced hepatocellular carcinoma eligible for ICIs
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Prior liver transplantation.
* patients with concurrent malignancies other than HCC.
* Active autoimmune disease requiring systemic immunosuppression.
18 Years
ALL
No
Sponsors
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Ahmed Karam Helmy
OTHER
Responsible Party
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Ahmed Karam Helmy
Use of immune checkpoint inhibitors in patients with advanced hepatocellular carcinoma : efficacy and outcomes
Locations
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Sohag university hospitals
Sohag, Sohag Governorate, Egypt
sSohag oncology centre
Sohag, Sohag Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
3. Liu, Y., Kalligeros, M., El-Serag, H. B., et al. (2022). Cancer Med, 11, 1310-1323.
2. McGlynn, K. A., Liu, Y., Kalligeros, M., et al. (2021). Hepatology, 73, 4-13.
1. Siegel, R. L., McGlynn, K. A., Liu, Y., et al. (2024). CA Cancer J Clin, 74, 12-49.
Other Identifiers
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Soh-Med--25-12-8MD
Identifier Type: -
Identifier Source: org_study_id
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