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Impact of Radiation Modality on Immune Responses in Patients with Esophageal Cancer and Unresectable or Locally Recurrent Hepatocellular Carcinoma Receiving a Pneumococcal Vaccine
Trial Status: active
The goal of this clinical research study is to learn how radiation treatment may affect responses to vaccines against pneumonia in patients with esophageal cancer and hepatocellular cancer that that cannot be removed by surgery (unresectable) or has come back after a period of improvement (locally recurrent).
Inclusion Criteria
GROUP 1A:
* Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons
GROUP 1B:
* Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT)
GROUP 2A:
* Patients currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable hepatocellular carcinoma
GROUP 2B:
* Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable hepatocellular carcinoma
GROUP 3:
* Healthy age- and gender- matched individuals
ALL GROUPS:
* Patients of all genders, races and nationalities will be solicited
* Age > 18 years
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* Patients with compromised immunologic responses due to an uncontrolled intercurrent immunodeficiency (e.g., Human immunodeficiency virus (HIV), X-linked agammaglobulinemia) or previous or current immune suppressive therapy
** Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* Patients receiving intravenous immunoglobulin (IVIG) during the study or in the three months prior to study enrollment
* Patients with psychiatric illness/social situations that would limit compliance with study requirements
* Individuals with previous pneumococcal vaccination in the last 5 years
* Individuals with severe allergy to any of the vaccine components
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06181656.
I. Determine the impact of grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination.
OUTLINE: This is an observational study.
Participants receive standard of care PCV20 or Prevnar-13 for patients who have no access to PCV20 vaccine, given via injection and undergo blood sample collection on study.
