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NCT Number: NCT07321067

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

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.

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Key information

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag university hospitals, Sohag, Sohag Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. ICI-Specific Survival (OS-ICI).

    Time frame: 12 months

    Time from ICI initiation to death or last follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Karam Helmy, MSc

CONTACT

[email protected]

2+01090784895

Sponsors and collaborators

Lead sponsor

Ahmed Karam Helmy

Other

Registry information

Acronym: ICIs

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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