Recruiting

Radiation Treatment

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06181656

Conditions

Pneumococcal Vaccine

Esophageal Cancer

Lymphopenia

Chemoradiation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Pneumonia vaccine

Study Details

Brief summary:

To learn how radiation treatment may affect your responses to vaccines against pneumonia.

Conditions

Pneumococcal Vaccine

Esophageal Cancer

Lymphopenia

Chemoradiation

Study ID

NCT06181656

Start date

Feb 5, 2024

Status verified date

May, 2026

Completion date

Jul 4, 2027

Anticipated

Primary completion date

Jul 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Group 1A

a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons.
2. Group 1B

a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT)
3. Group 2A

a. Patients currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable liver cancer.
4. Group 2B

a. Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable liver cancer.
5. Group 3

a. Healthy age- and gender- matched individuals
6. All Groups

1. Patients of all genders, races and nationalities will be solicited.
2. Age >18 years
3. 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

a. 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 Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

30 participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer. This group will be subdivided into Group 1A, which will comprise 15 participants treated with proton therapy, and Group 1B, which will comprise 15 patients treated with intensity modulated radiation therapy (IMRT).

Group 2

30 participants currently receiving, planning to receive, or recently completed chemoradiation for hepatocellular carcinoma. This group will be subdivided into Group 2A, which will comprise 15 participants treated with proton therapy, and Group 2B, which will comprise 15 patients treated with intensity modulated radiation therapy (IMRT).

Group 3

20 Healthy Volunteers.

Interventions

Pneumonia vaccine

Given by SC

Primary outcome measure

  • Impact of grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination [ Time Frame: through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 20, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-20.