Actively Recruiting
Serologic Response to Pneumococcal Vaccination Among Esophageal and Liver Cancer Patients With High Grade Lymphopenia After Chemoradiation
Led by M.D. Anderson Cancer Center · Updated on 2026-05-20
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how radiation treatment affects the immune response to pneumococcal vaccines in patients with esophageal cancer who have severe lymphopenia caused by chemoradiation. The study also looks at the effects of chemoradiation and different radiation methods on immunity, pneumonia incidence, tumor response, and clinical outcomes. The research includes healthy volunteers for comparison. The study includes three groups: esophageal cancer patients receiving proton therapy or intensity-modulated radiation therapy (IMRT), liver cancer patients treated with proton therapy or IMRT, and healthy volunteers matched by age and gender. Participants receive the pneumonia vaccine by subcutaneous injection. The study observes participants during and after their cancer treatment to evaluate immune responses and related health effects. Participants will be monitored through the course of the study, which lasts about one year on average. Researchers will measure how severe lymphopenia affects vaccine response, track pneumonia cases, and assess immune changes in the blood and tumors. Consent and willingness to participate are required, and healthy volunteers are included for comparison. The study is sponsored by M.D. Anderson Cancer Center.
CONDITIONS
Brief Title
Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with proton therapy (Group 1A)
- Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT) (Group 1B)
- Patients currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable liver cancer (Group 2A)
- Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable liver cancer (Group 2B)
- Healthy age- and gender-matched individuals (Group 3)
- Patients of all genders, races, and nationalities
- Age over 18 years
- Ability to understand and willingness to sign a written informed consent document
You will not qualify if you...
- Patients with uncontrolled immunodeficiency such as HIV or previous/current immune suppressive therapy
- Patients receiving intravenous immunoglobulin (IVIG) during the study or in the three months prior
- Patients with psychiatric illness or social situations limiting study compliance
- Individuals who had pneumococcal vaccination in the last 5 years
- Individuals with severe allergy to any vaccine components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive the pneumococcal vaccine by subcutaneous injection.
1 visit (in-person)
Duration - Up to 1 year
Participants are monitored to determine their serologic response to the pneumococcal vaccination and the impact of chemoradiation and radiation modality on immunity.
Multiple visits depending on group assignment and follow-up schedule
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Steven H Lin, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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