NCT07321067

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Ahmed Karam Helmy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Hepatocellular Carcinoma (HCC)

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

2 sites across 1 country: Egypt