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

December 21, 2025 updated by: Ahmed Karam Helmy

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients diagnosed with advanced hepatocellular carcinoma either denovoor after prior line of treatment

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
all patients diagnosed with advanced hepatocellular carcinoma eligible for ICIs

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmed Karam Helmy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

December 21, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Soh-Med--25-12-8MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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