SARS-CoV-2 mRNA Vaccination in Patients With Hepatocellular Carcinoma Treated With Immune Checkpoint Inhibitors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMedical University of Graz
About this trial
A multicenter retrospective cohort analysis in Austria
Primary Objective:
To assess whether receiving an mRNA COVID-19 vaccine within 3 months before starting ICI (Immune checkpoint inhibitors) therapy improves best overall response (mRECIST) in HCC (hepatocellular carcinoma).
Secondary Objectives:
Evaluate whether vaccination within 1 or 3 months affects OS (overall survival) , PFS (Progression free survival)), or TTP (Time to progression); compare outcomes by vaccination status, vaccine type, and prior infection; explore modification by cirrhosis severity and tumor characteristics; and assess safety (irAEs, steroid use, toxicity-related discontinuation).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Radiologically or histologically confirmed hepatocellular carcinoma
Treatment with immune checkpoint inhibitor-based therapy (mono- or combination therapy; e.g., atezolizumab/bevacizumab, durvalumab/tremelimumab, nivolumab, pembrolizumab)
Complete electronic medical records available
Disqualifiers
Missing key clinical data required for main analyses (e.g. survival status, date of progression, Child-Pugh class, BCLC stage)
Trial population
The study will include all eligible patients with HCC treated within the past 5 years (January 2021 - December 2025, depending on center availability) with one of the specified checkpoint inhibitors
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Vaccinated
Group B: not vaccinated
Trial outcomes
Primary outcomes
1
Best overall response
according to mRECIST criteria
Time frame
up to 4 yearsSecondary outcomes
1
Overall survival
death yes/no
Time frame
up to 4 years2
Progression free survival
Progression according to RECIST yes/no
Time frame
up to 4 years3
Time to progression
Time until progression occurs according to RECIST
Time frame
up to 4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of Graz
Lead sponsor
Klinikum Wels-Grieskirchen
Collaborator
University Hospital St. Polten
Collaborator
Ordensklinikum Linz GmbH Krankenhaus Barmherzige Schwestern
Collaborator
Krankenhaus der Barmherzigen Brüder St. Veit/Glan
Collaborator
Source ClinicalTrials.gov