An observational study in mRNA Vaccination, Hepatocellular Carcinoma and Checkpoint Inhibitor, sponsored by Medical University of Graz. Not yet recruiting at 5 sites in Austria. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Medical University of Graz · Observational
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).
Immune checkpoint inhibitors (ICIs) have become a cornerstone of systemic therapy for advanced hepatocellular carcinoma (HCC). Their efficacy, however, varies substantially between patients, and factors that modulate immunotherapy response remain incompletely understood .
Recent mechanistic and clinical data have raised the hypothesis that SARS-CoV-2 mRNA vaccines might augment responsiveness to ICIs. A landmark study by Grippin et al. demonstrated that mRNA vaccines induce a systemic surge of type-I interferons, activate antigen-presenting cells, increase PD-L1 expression on tumor cells, and ultimately sensitize tumors to ICIs across various malignancies including NSCLC (non-small cell lung cancer) and melanoma. In their retrospective cohorts, receiving a COVID-19 mRNA vaccine within 100 days before starting ICI was associated with significantly improved overall survival and progression-free survival While these findings suggest that COVID-19 mRNA vaccines may act as potent immune modulators in the context of immunotherapy, no data exist for HCC, a tumor entity that is characterized by an immunosuppressive, 'immune-cold' microenvironment that limits effective anti-tumor immune responses.
Given the widespread implementation of COVID-19 vaccination programs in Austria since 2021, and the large number of HCC patients receiving ICI-based therapies at tertiary centers, a rigorous retrospective analysis is now feasible.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Patients with hepatocellular carcinoma, undergoing checkpoint inhibitor therapy, vaccinated with mRNA vaccine within last 100 days
Patients with hepatocellular carcinoma, undergoing checkpoint inhibitor therapy, not vaccinated with mRNA vaccine within last 100 days
Best overall response
according to mRECIST criteria
Time frame: up to 4 years
Overall survival
death yes/no
Time frame: up to 4 years
Progression free survival
Progression according to RECIST yes/no
Time frame: up to 4 years
Time to progression
Time until progression occurs according to RECIST
Time frame: up to 4 years
Plan to share: Yes — Upon request and after having a data sharing agreement in place, pseudonymized IPD can be shared.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Medical University of Graz