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

NCT07341321 | Not Yet Recruiting

• 1 other identifier: CoVaCheck
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

Brief 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

mRNA Vaccination; Hepatocellular Carcinoma; Checkpoint Inhibitor

Keywords

hepatocellular carcinoma; mRNA vaccination; response; immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (1)

• Best overall response

  according to mRECIST criteria

  up to 4 years

Secondary Outcomes (3)

• Overall survival

  up to 4 years

• Progression free survival

  up to 4 years

• Time to progression

  up to 4 years

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Missing key clinical data required for main analyses (e.g. survival status, date of progression, Child-Pugh class, BCLC stage)

Sponsors & Collaborators

• Medical University of Graz: lead
• Klinikum Wels-Grieskirchen: collaborator
• University Hospital St. Polten: collaborator
• Ordensklinikum Linz GmbH Krankenhaus Barmherzige Schwestern: collaborator
• Krankenhaus der Barmherzigen Brüder St. Veit/Glan: collaborator

Study Sites (5)

Medical University of Graz

Graz, 8010, Austria

Location

Ordensklinikum Linz

Linz, Austria

Location

University Hospital St. Pölten

Sankt Pölten, Austria

Location

Krankenhaus der Barmherzigen Brüder St Veit an der Glan

Sankt Veit an der Glan, Austria

Location

Klinikum Wels-Grieskirchen

Wels, Austria

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Florian Rainer, MD

  Medizinische Universität Graz

  PRINCIPAL INVESTIGATOR

• Vanessa Stadlbauer, Univ Prof

  Medizinische Universität Graz

  PRINCIPAL INVESTIGATOR

• Walter Spindelböck, MD

  Medizinische Universität Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Rainer, MD

CONTACT

+43 316 385; florian.rainer@medunigraz.at

Vanessa Stadlbauer, Univ. Prof. MD

CONTACT

+43 316 385; vanessa.stadlbauer@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 14, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

AU (5)