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

Sponsor
Medical University of Graz
Study ID
NCT07341321
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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).

Key Dates

First listed
Jan 14, 2026
Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Vaccinated
    Patients with hepatocellular carcinoma, undergoing checkpoint inhibitor therapy, vaccinated with mRNA vaccine within last 100 days
  • Arm: not vaccinated
    Patients with hepatocellular carcinoma, undergoing checkpoint inhibitor therapy, not vaccinated with mRNA vaccine within last 100 days

Primary Outcome Measure

Best overall response [ Time Frame: up to 4 years ]

Central Contacts

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