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).
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
Missing key clinical data required for main analyses (e.g. survival status, date of progression, Child-Pugh class, BCLC stage)
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
Case-control
Retrospective
Not listed
Best overall response
according to mRECIST criteria
Overall survival
death yes/no
Progression free survival
Progression according to RECIST yes/no
Time to progression
Time until progression occurs according to RECIST
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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
This trial is not recruiting at the moment. You can still explore other options:
