mRNA VaccinationCoVaCheckNCT07341321
SARS-CoV-2 mRNA Vaccination in Patients With Hepatocellular Carcinoma Treated With Immune Checkpoint Inhibitors
An observational study of mRNA Vaccination and Hepatocellular Carcinoma, run by Medical University of Graz at 5 sites in Austria.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- mRNA Vaccination, Hepatocellular Carcinoma, Checkpoint Inhibitor
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- 5 sitesAustria
- Study dates
- 1 Jan 2026to Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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
Who may be able to join
- 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
- At least one imaging-based response assessment using mRECIST
Who cannot join
- Missing key clinical data required for main analyses (e.g. survival status, date of progression, Child-Pugh class, BCLC stage)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Austria5 sites, 5 recruiting
- Recruiting
Medical University of Graz
Graz, 8010
Florian Rainer, MD, +43 316 385, florian.rainer@medunigraz.at
- Not yet recruiting
Ordensklinikum Linz
Linz
Stephanie Hametner-Schreil, +43 732 7677, Stephanie.Hametner-Schreil@ordensklinikum.at
- Not yet recruiting
University Hospital St. Pölten
Sankt Pölten
Anderas Maieron, MD, +43 27429004, andreas.maieron@stpoelten.lknoe.at
- Recruiting
Krankenhaus der Barmherzigen Brüder St Veit an der Glan
Sankt Veit an der Glan
Ute Enökl-Tomantschger, MD, +43 4212 499, Ute.Enoekl-Tomantschger@bbstveit.at
- Not yet recruiting
Klinikum Wels-Grieskirchen
Wels
Harald Hofer, MD, +43 7242 415 - 2181, harald.hofer@klinikum-wegr.at
About this study
Official title: SARS-CoV-2 mRNA Vaccination in Patients With Hepatocellular Carcinoma Treated With Immune Checkpoint Inhibitors (CoVaCheck) A Multicenter Retrospective Cohort Analysis in Austria
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).
Read the detailed description
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.
- Keywords
- hepatocellular carcinoma, mRNA vaccination, response, immune checkpoint inhibitor
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated | Patients with hepatocellular carcinoma, undergoing checkpoint inhibitor therapy, vaccinated with mRNA vaccine within last 100 days | |
| not vaccinated | Patients with hepatocellular carcinoma, undergoing checkpoint inhibitor therapy, not vaccinated with mRNA vaccine within last 100 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best overall response
according to mRECIST criteria
Measured: up to 4 years
Secondary outcomes (3)
Overall survival
death yes/no
Measured: up to 4 years
Progression free survival
Progression according to RECIST yes/no
Measured: up to 4 years
Time to progression
Time until progression occurs according to RECIST
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Jan 2026
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mRNA VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Wels-Grieskirchen, University Hospital St. Polten, Ordensklinikum Linz GmbH Krankenhaus Barmherzige Schwestern, Krankenhaus der Barmherzigen Brüder St. Veit/Glan
- Responsible party
- Sponsor
- Investigators
- Florian Rainer, MD, Principal investigator, Medizinische Universität GrazVanessa Stadlbauer, Univ Prof, Principal investigator, Medizinische Universität GrazWalter Spindelböck, MD, Principal investigator, Medizinische Universität Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341321
- Sponsor's protocol ID
- CoVaCheck
- Acronym
- CoVaCheck
- Status last verified
- Oct 2026
- First submitted
- 15 Dec 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request and after having a data sharing agreement in place, pseudonymized IPD can be shared.