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ClinicalTrials.gov ID

NCT07321067

Lead Sponsor

Ahmed Karam HelmyOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

75Estimated

Last Update Posted

Jan 6, 2026Actual

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Nov 1, 2026Estimated

Completion Date

Nov 1, 2027Estimated

Official Title

Use of Immune Checkpoint Inhibitors in Patients With Advanced Hepatocellular Carcinoma : Efficacy and Outcomes

Brief Summary

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.

• Advanced Hepatocellular Carcinoma (HCC)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Ahmed Karam HelmyOTHER

ahmed011028@med.sohag.edu.eg2+01090784895