COVID-19 mRNA vaccine before immune therapy for liver cancer
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
Run by Medical University of Graz · NCT07341321 · Data updated 2026-11-12
This study looks at whether getting an mRNA COVID-19 vaccine within a few months before starting immune checkpoint therapy helps liver cancer patients respond better to treatment.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Medical University of Graz Academic / other |
| Drugs / interventions | atezolizumab, bevacizumab, durvalumab, tremelimumab, nivolumab, pembrolizumab, immunotherapy |
| Locations | 5 sites (Graz and 4 other locations) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | July 2027 |
| Study ends | December 2027 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT07341321 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with radiologically or histologically confirmed hepatocellular carcinoma who are receiving ICI-based therapy and have complete medical records with at least one mRECIST-based imaging assessment.
✕Probably not a fit
Patients without available vaccination timing data, with missing key outcomes, or whose disease biology does not respond to immunotherapy may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter retrospective analysis from Austria examining adults with hepatocellular carcinoma who receive immune checkpoint inhibitors. The main question is whether an mRNA COVID-19 vaccine given within 3 months prior to ICI therapy improves the best overall tumor response by mRECIST. Secondary aims include impact on overall survival, progression-free survival, and time to progression, as well as differences by vaccine type and prior infection; with exploration of cirrhosis severity and tumor characteristics as potential modifiers. Safety outcomes such as immune-related adverse events and treatment discontinuation are also assessed. Data are drawn from complete electronic medical records and imaging-based assessments at participating centers.
Why it matters
Potential benefit: If vaccination around the start of ICI therapy is associated with better tumor responses or survival, it could inform timing of vaccination and treatment planning for HCC patients.
How similar studies have gone: Prior work suggests mRNA vaccination can modulate anti-tumor immunity in some cancers, but data in HCC are limited and this analysis is among the first in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Missing key clinical data required for main analyses (e.g. survival status, date of progression, Child-Pugh class, BCLC stage)
Where it's running
-
Medical University of Graz
Graz, Austria Recruiting -
Krankenhaus der Barmherzigen Brüder St Veit an der Glan
Sankt Veit an der Glan, Austria Recruiting -
Ordensklinikum Linz
Linz, Austria Not yet recruiting -
University Hospital St. Pölten
Sankt Pölten, Austria Not yet recruiting -
Klinikum Wels-Grieskirchen
Wels, Austria Not yet recruiting
Study contacts
- Principal investigator: Florian Rainer, MD — Medizinische Universität Graz
- Study coordinator: Florian Rainer, MD
- Email: florian.rainer@medunigraz.at
- Phone: +43 316 385
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
InstaSure Non-Invasive Finger-Press Test for HCC
This study tests a non-invasive finger-skin test to help identify hepatocellular carcinoma in adults.
-
BGB-B2033 vs Sorafenib or Lenvatinib for advanced liver cancer
This study tests whether the investigational drug BGB-B2033 can help people with advanced hepatocellular carcinoma when given after prior PD-1/PD-L1 therapy, compared with the standard medicines sorafenib or lenvatinib.
-
Zinc add-on with targeted therapy plus immunotherapy for advanced liver cancer
This study tests whether adding daily zinc to standard targeted therapy and immunotherapy helps people with unresectable or advanced hepatocellular carcinoma.
-
68Ga-SorB PET/CT imaging for solid tumors
This study tests a new PET tracer called 68Ga-SorB to see if it can safely and accurately detect tumors in adults with melanoma, liver, lung, breast, pancreatic, ovarian cancer, or cholangiocarcinoma.
-
Hepatocellular Carcinoma Patient Registry (CHARM Hepatocellular Carcinoma MEA)
This observational study collects medical records of adults with hepatocellular carcinoma to understand how the disease presents and progresses across regions in the Middle East and North Africa.
-
GLP-1 RA plus standard treatment in first-line metastatic GI cancers
This early-phase trial tests whether adding a GLP-1 receptor agonist to standard first-line chemotherapy is safe and feasible for people with metastatic pancreatic, colorectal, or liver cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.