Use of Immune Checkpoint Inhibitors in Patients With Advanced Hepatocellular Carcinoma : Efficacy and Outcomes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAhmed Karam Helmy
About this trial
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.
Eligibility criteria
Qualifiers
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) .
Disqualifiers
Child-Pugh C liver function.
Prior liver transplantation.
patients with concurrent malignancies other than HCC.
Active autoimmune disease requiring systemic immunosuppression.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
75 Participants
are grouped into 1 trial groupSponsors and collaborators
Ahmed Karam Helmy
Lead sponsor
Sohag University
Sponsor institution
Source ClinicalTrials.gov