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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07321067

Acronym

ICIs

Enrollment

Registered

2026-01-06

Start date

2026-01-01

Completion date

2027-11-01

Last updated

2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Keywords

advanced hepatocellular carcinoma, immune checkpoint inhibitors

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
ICI-Specific Survival (OS-ICI).	12 months	Time from ICI initiation to death or last follow-up.

Countries

Egypt

Contacts

Primary ContactAhmed Karam Helmy, MSc

ahmed011028@med.sohag.edu.eg2+01090784895

Outcome results