Recruiting
Phase 2

LNSC

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT07222657

Conditions

Esophageal Adenocarcinoma

Esophageal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of care chemotherapy

LNSC

Study Details

Brief 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.

Conditions

Esophageal Adenocarcinoma

Esophageal Cancer

Study ID

NCT07222657

Start date

Jun 10, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Standard of care chemotherapy

Participants will receive neoadjuvant therapy per FLOT protocol +/- Durvalumab for up to 6 cycles. Each cycle is two weeks.

The FLOT protocol is a standard of care protocol involving chemotherapy before and after esophagectomy with fluorouracil, leucovorin, oxaliplatin, and docetaxel.

Durvalumab is administered intravenously (IV) and dosed at 1500 milligrams (mg). It is given on Day 1 of each cycle.

LNSC

LNSC will be administered via endoscopy. LNSC will be performed with liquid nitrogen (<5 psi) at 25 watts using a cryotherapy catheter passed through the working channel of the endoscope. Up to three cycles of 20 to 40 seconds of cryotherapy will be administered and each directed at the bulkiest aspect of the tumor. During each cycle, a surface area of approximately 2 to 3 cm2 is targeted, and up to three sites are targeted during each session.

Participants will receive two sessions of LNSC. The first will be upon entry into the study. The second will be 1-2 weeks after the first session.

Primary outcome measure

  • Complete response (CR) rates [ Time Frame: At treatment discontinuation, up to 12 weeks ]

Central Contacts and Locations

Central contacts

Tilak Shah, MD

561-497-8859shaht3@ccf.org

Locations

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Principal Investigator:

Tilak Shah, MD

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Liquid Nitrogen Spray Cryotherapy
  • LNSC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-18.