Impact of Chemoradiation on Pneumococcal Vaccine Response in Esophageal Cancer Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess how radiation treatment affects the immune response to pneumococcal vaccination in patients with esophageal cancer who experience high-grade lymphopenia after chemoradiation. The primary objective is to determine the impact of Grade IV radiation-induced lymphopenia on serologic responses to the vaccine. Secondary objectives include evaluating the effects of different radiation modalities on vaccine response, systemic immunity, and the incidence of pneumonia among vaccinated patients. The study will also explore the relationship between immune changes and clinical outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Steven H Lin, MD — M.D. Anderson Cancer Center
• Study coordinator: Steven H Lin, MD
• Email: shlin@mdanderson.org
• Phone: (713) 563-8490

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant treatments for esophageal cancer

  This study is testing different combinations of treatments for people with esophageal cancer to see if they can improve outcomes compared to just having surgery.

  Recruiting Phase 3 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing · NCT04821843

• Evaluating quality of life in esophageal cancer patients after chemoradiation

  This study is trying to see how treatment with chemoradiation affects the quality of life for people with esophageal cancer.

  Recruiting Ludwig-Maximilians - University of Munich · Munich, Bavaria · NCT03712774

• PF-08098488 in adults with advanced solid tumors

  This study tests PF-08098488 in adults whose cancer has progressed or returned after prior treatment.

  Recruiting at 4 sites Phase 1 Pfizer · Grand Rapids, Michigan and 3 other locations · NCT07903415

• Modular Robot-Assisted Esophagectomy vs. Conventional Minimally Invasive Esophagectomy for Esophageal Cancer

  This trial tests whether modular robotic-assisted esophagectomy using the Carina platform works better than conventional 3D thoracoscopic esophagectomy for people with resectable esophageal cancer.

  Recruiting Phase 3 Ruijin Hospital · Shanghai · NCT07888140

• MGC030 in adults with advanced solid tumors

  This trial tests MGC030 in adults with advanced urothelial, gastric/GEJ, esophageal, colorectal, gastric, pancreatic, or GEJ cancers to see if it is safe and whether it can shrink tumors or stop growth.

  Recruiting Phase 1 MacroGenics · Lake Success, New York · NCT07822399

• Adding 2141-V11 to standard therapy for advanced esophageal, gastric, or gastroesophageal junction cancer

  This study tests whether adding the drug 2141-V11 to standard anti-PD-1 therapy (with or without 5-FU) is safe for adults with advanced or metastatic esophageal, gastric, or gastroesophageal junction adenocarcinoma.

  Recruiting at 7 sites Phase 1/2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07818018

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.