NCT07222657RecruitingPhase 2
Liquid Nitrogen Spray Cryotherapy Prior to Neoadjuvant Systemic Therapy in Esophageal Adenocarcinoma
Phase 2 Randomized Trial Of Liquid Nitrogen Spray Cryotherapy Prior To Neoadjuvant Systemic Therapy In Locally Advanced Esophageal Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 28 Oct 2025
- Start date
- 10 Jun 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Case Comprehensive Cancer Center
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07222657
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 10 Jun 2026 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Coagulopathy (INR \> 2 or platelet count \< 50,000 per cubic millimeter)
- Risk of thrombosis is determined to be too high to hold anti-platelets (other than aspirin) or anticoagulants prior to the procedure.
Other
- Inability to pass the orogastric decompression tube into the stomach
- Inability to provide informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status \> 2
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Florida Coordinator of this site? Confirm its status | Weston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.