Clinical Trial

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

Study acronym: CoVaCheck
Not Yet Recruiting
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Record status
This record was last updated January 14, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
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). 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 2026-01
Primary Completion 2026-07 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-14