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SARS-CoV-2 mRNA Vaccination in Patients With Hepatocellular Carcinoma Treated With Immune Checkpoint Inhibitors

Study acronym: CoVaCheck
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jul 2026 → Jul 2027
See other at-risk trials from Medical University of Graz

Record History

  1. Primary completion pushed from Jul 2026 to Jul 2027 Recruitment opened · Completion pushed from Dec 2026 to Dec 2027 · Start date changed from estimate of Jan 2026 to Jan 1, 2026 · 4 more Show 7 more changesShow less
    • Recruitment opened
    • Completion pushed from Dec 2026 to Dec 2027
    • Start date changed from estimate of Jan 2026 to Jan 1, 2026
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised at 5 of 5 sites
    • Collaborators: details revised at 1 of 4 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07341321
Lead Sponsor Medical University of Graz
Collaborators: Klinikum Wels-Grieskirchen, University Hospital St. Polten, Ordensklinikum Linz GmbH Krankenhaus Barmherzige Schwestern, Krankenhaus der Barmherzigen Brüder St. Veit/Glan
Conditions mRNA Vaccination, Hepatocellular Carcinoma, Checkpoint Inhibitor
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov