Use of Immune Checkpoint Inhibitors in Patients With Advanced Hepatocellular Carcinoma : Efficacy and Outcomes
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Ahmed Karam Helmy
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- ICI-Specific Survival (OS-ICI).
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
all patients diagnosed with advanced hepatocellular carcinoma eligible for ICIs
Outcomes
Primary Outcomes
ICI-Specific Survival (OS-ICI).
Time Frame: 12 months
Time from ICI initiation to death or last follow-up.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ahmed Karam Helmy
Use of immune checkpoint inhibitors in patients with advanced hepatocellular carcinoma : efficacy and outcomes
Sohag University