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Liquid Nitrogen Spray Cryotherapy for Esophageal Adenocarcinoma

This study is for adults with locally advanced esophageal adenocarcinoma (a type of cancer in the tube connecting your mouth to your stomach) who are planning to receive chemotherapy. It's testing if adding Liquid Nitrogen Spray Cryotherapy (LNSC) to standard chemotherapy (FLOT protocol +/- Durvalumab) is more effective than chemotherapy alone. LNSC uses liquid nitrogen to freeze and damage cancer cells. You would be randomly assigned to either receive LNSC in addition to chemotherapy, or chemotherapy alone. The main goal is to see if more people have a complete response (meaning the cancer is no longer detectable) by the end of treatment, up to 12 weeks.

Study design
This interventional study plans to enroll 40 participants. You would be randomly assigned to one of two groups: LNSC plus chemotherapy, or chemotherapy alone.
What's involved
If you are in the LNSC group, you would undergo two sessions of LNSC through an upper endoscopy. All participants would receive standard chemotherapy (FLOT protocol +/- Durvalumab) for up to six cycles, with each cycle lasting two weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of complete response is measured at treatment discontinuation, up to 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07222657

Liquid Nitrogen Spray Cryotherapy Prior to Neoadjuvant Systemic Therapy in Esophageal Adenocarcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Case Comprehensive Cancer Center
~40 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Standard of care chemotherapyLNSC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete response (CR) rates
Measured over At treatment discontinuation, up to 12 weeks

Conditions

Esophageal Adenocarcinoma
Esophageal Cancer

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Esophageal Adenocarcinoma

NCT07222657

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cleveland Clinic Florida

    Weston, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tilak Shah, MD · PRINCIPAL_INVESTIGATOR · Case Comprehensive Cancer Center, Cleveland Clinic Florida

Who to contact

Tilak Shah, MD
[email protected]
561-497-8859
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

Inability to pass the orogastric decompression tube into the stomach
Coagulopathy (INR \> 2 or platelet count \< 50,000 per cubic millimeter)
Inability to provide informed consent
Eastern Cooperative Oncology Group (ECOG) performance status \> 2
Risk of thrombosis is determined to be too high to hold anti-platelets (other than aspirin) or anticoagulants prior to the procedure.

What this trial measures

  • Complete response (CR) ratesAt treatment discontinuation, up to 12 weeks

    CR is defined as the absence of tumor on re-staging scans and explant or mucosal biopsies (if applicable).