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

NCT07341321 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-01-14

No results posted yet for this study

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).

Conditions

Sponsors & Collaborators

  • Klinikum Wels-Grieskirchen

    collaborator OTHER

  • University Hospital St. Polten

    collaborator OTHER

  • Ordensklinikum Linz GmbH Krankenhaus Barmherzige Schwestern

    collaborator UNKNOWN

  • Krankenhaus der Barmherzigen Brüder St. Veit/Glan

    collaborator UNKNOWN

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Florian Rainer, MD · Medizinische Universität Graz

  • Vanessa Stadlbauer, Univ Prof · Medizinische Universität Graz

  • Walter Spindelböck, MD · Medizinische Universität Graz

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-07-31
Completion
2026-12-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07341321 on ClinicalTrials.gov