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

Ahmed Karam Helmy

Status: Not yet enrolling

Conditions: Advanced Hepatocellular Carcinoma (HCC)

Study type: Observational

Funder types: Other

Identifiers

NCT07321067

Soh-Med--25-12-8MD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

75 participants in 1 patient group

all patients diagnosed with advanced hepatocellular carcinoma eligible for ICIs