Cryotherapy for Esophageal Cancer
Trial Summary
What is the purpose of this trial?
Background: In published studies, complete response (CR) to chemoradiation occurs in only 25-30% of patients with locally advanced esophageal cancer. Liquid nitrogen spray cryotherapy (LNSC) is postulated to stimulate an anti-tumor immune response. In a preliminary study, the investigators documented CR rate of 56% with a single session of LNSC administered prior to chemoradiation. Before proceeding with larger trials to corroborate these findings, the maximally tolerated dose (MTD) of neoadjuvant LNSC must be determined. The aims of this study are: (1) To determine safety and MTD of LNSC during neoadjuvant chemoradiation in locally advanced esophageal cancer. (2) To assess whether LNSC results in immunogenic cell death. (3) To assess changes in tumor micro-environment with LNSC. Methods: Eligible adult patients with locally advanced esophageal cancer will receive LNSC at the following dose frequencies: Patient 1, 2, and 3: 2 sessions of LNSC prior to chemoradiation (chemoXRT); Patients 4, 5, and 6: 2 sessions LNSC prior to chemoXRT, then 1 session during week 4 of chemoXRT; Patients 7, 8, and 9: 2 sessions LNSC prior to chemoXRT, then 1 session during week 2 and 1 session during week 4 of chemoXRT. If no dose limiting toxicity (DLT) occurs, the investigators will enroll an additional 3 patients to confirm MTD. The investigators will contact patients at 48-hours and 1-week post-procedure to evaluate for adverse events (AEs) and DLTs, and assess for improvements in dysphagia and quality of life (QOL) using the Mellow-Pinkas and EORTC QLQ-OES18 instruments respectively. The investigators will obtain peripheral blood for ELISA and biopsies from the tumor to assess tumor-infiltrating lymphocytes (TILs) and T cell subtypes before the 1st session of LNSC, before the 2nd session of LNSC, and after chemoradiation is completed. Expected results: (1) Dose limiting toxicity (DLT) does not occur when patients received 2 session of LNSC prior to chemoXRT, and 2 sessions during chemoXRT (2) LNSC results in immunogenic cell death, as assessed by increased levels of HMGB1 in serum, and calreticulin in biopsy specimens (CRT) (3) LNSC is associated with increased T cell infiltration and activation (increased TILs, CD8+, CD3+ T cells, and granzyme B), and decrease in regulatory T cells (CD45R0, FOXP3).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Cryotherapy for Esophageal Cancer?
Research shows that cryotherapy, which involves freezing cancer cells, is effective and safe for treating esophageal cancer, especially in early stages and when combined with other treatments like chemotherapy. Studies have demonstrated longer survival rates and fewer complications compared to traditional chemotherapy alone.12345
Is cryotherapy safe for treating esophageal conditions?
Cryotherapy, including endoscopic cryotherapy using liquid nitrogen, has been shown to be generally safe for treating esophageal conditions like Barrett's esophagus and early-stage esophageal cancer. Common side effects include chest pain, difficulty swallowing, and sore throat, but these are usually short-lived. Serious complications are rare, but can include esophageal strictures and, very rarely, gastric perforation.14678
How is cryotherapy different from other treatments for esophageal cancer?
Cryotherapy is unique because it uses extreme cold to destroy cancer cells in the esophagus, offering a non-surgical option that can be used for both early-stage and advanced esophageal cancer. It involves cycles of freezing and thawing, which cause cell death and can be applied endoscopically, making it less invasive than traditional surgery.1291011
Research Team
Tilak Shah, MD
Principal Investigator
McGuire VA Medical Center
Eligibility Criteria
Adults with locally advanced esophageal cancer, confirmed by specific tests and without distant metastases. They must be able to undergo procedures required for the trial and not have severe coagulopathy, a very poor performance status (ECOG ≥3), or be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Cryotherapy
Participants receive 2 sessions of liquid nitrogen spray cryotherapy prior to chemoradiation
Chemoradiation
Participants undergo concurrent chemoradiation for 5 weeks, with additional cryotherapy sessions depending on the group
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and quality of life
Treatment Details
Interventions
- Cryotherapy
Cryotherapy is already approved in European Union, United States, Canada for the following indications:
- Pain relief
- Inflammation reduction
- Muscle spasm treatment
- Rheumatoid arthritis
- Stress and anxiety relief
- Pain management
- Muscle soreness reduction
- Recovery after exercise
- Fibromyalgia treatment
- Skin health improvement
- Pain relief
- Inflammation reduction
- Muscle spasm treatment
- Arthritis management
- Postpartum recovery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hunter Holmes Mcguire Veteran Affairs Medical Center
Lead Sponsor
McGuire Research Institute
Collaborator