Esophageal Cancer Clinical Trials

Find Esophageal Cancer Clinical Trials Near You

Phase 2 Randomized Trial Of Liquid Nitrogen Spray Cryotherapy Prior To Neoadjuvant Systemic Therapy In Locally Advanced Esophageal Adenocarcinoma

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This research study is for people who have locally advanced esophageal adenocarcinoma and are expected to receive chemotherapy. The purpose of this study is to compare the effectiveness of Liquid Nitrogen Spray Cryotherapy (LNSC) in addition to chemotherapy versus chemotherapy alone in the treatment of esophageal adenocarcinoma. LNSC is an FDA approved device that works by using liquid nitrogen to rapidly cool cancerous tissue causing cell damage. Participants in this study will be randomly assigned to either the LNSC group or the No-LNSC group. Participants in the LNSC group will undergo 2 sessions of LNSC through an upper endoscopy. Participants in the No-LNSC group, may undergo an endoscopy if needed for symptoms such as difficulty swallowing. Participation in the research will last about 4 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults with locally advanced EAC who are expected to receive FLOT +/-Durvalumab will be eligible to participate.

• Locally advanced esophageal cancer is defined as TNM stages T1N+M0 or T2-T4aNanyM0, as defined by endoscopic ultrasound (EUS) and PET-CT.

Locations
United States
Florida
Cleveland Clinic Florida
RECRUITING
Weston
Contact Information
Primary
Tilak Shah, MD
shaht3@ccf.org
561-497-8859
Time Frame
Start Date: 2026-06-10
Estimated Completion Date: 2027-09
Participants
Target number of participants: 40
Treatments
Experimental: Liquid Nitrogen Spray Cryotherapy (LNSC) + Standard of care chemotherapy
Participants will receive a standard of care chemotherapy, neoadjuvant FLOT +/- durvalumab WITH LNSC.
Other: Standard of care chemotherapy
Participants will receive a standard of care chemotherapy, neoadjuvant FLOT +/- durvalumab WITHOUT LNSC.
Related Therapeutic Areas
Sponsors
Collaborators: Salgi Foundation
Leads: Case Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov