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

ConditionAdvanced Hepatocellular Carcinoma (HCC)

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

This trial does not accept healthy volunteers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

75 Participants

are grouped into 1 trial group

Group A: all patients diagnosed with advanced hepatocellular carcinoma eligible for ICIs

Trial outcomes

Primary outcomes

ICI-Specific Survival (OS-ICI).

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

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ahmed Karam Helmy

Lead sponsor

Sohag University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: