Liquid Nitrogen Spray Cryotherapy for Esophageal Cancer

Overseen By Tilak Shah, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Comprehensive Cancer Center

Must be taking: Chemotherapy

Must not be taking: Anti-platelets, Anticoagulants

Disqualifiers: Coagulopathy, High thrombosis risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating esophageal cancer by combining Liquid Nitrogen Spray Cryotherapy (LNSC) with chemotherapy. LNSC uses extremely cold liquid nitrogen to target and damage cancer cells. The study aims to determine if adding LNSC to standard chemotherapy is more effective than chemotherapy alone. Participants will be randomly assigned to one of two groups: one receiving both LNSC and chemotherapy, and the other receiving only chemotherapy. This trial is suitable for adults with locally advanced esophageal adenocarcinoma who are about to begin chemotherapy. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, if you are taking anti-platelets (except aspirin) or anticoagulants, you may need to stop them if the risk of thrombosis (blood clots) is too high.

What prior data suggests that this device is safe for esophageal cancer treatment?

Research has shown that Liquid Nitrogen Spray Cryotherapy (LNSC) is generally safe for treating esophageal cancer. One study found that LNSC caused only minor side effects, and most participants tolerated it well. Another study reported few serious issues, such as esophageal narrowing, when LNSC was used for more advanced esophageal cancer. Overall, LNSC appears safer compared to more invasive treatments like surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for esophageal cancer?

Researchers are excited about Liquid Nitrogen Spray Cryotherapy (LNSC) for esophageal cancer because it introduces a novel method of targeting cancer cells. Unlike traditional chemotherapy, which uses drugs to kill cancer cells throughout the body, LNSC works by directly freezing and destroying cancerous tissue in the esophagus. This precise approach helps to minimize damage to surrounding healthy tissue, potentially leading to fewer side effects compared to standard treatments. Moreover, combining LNSC with standard chemotherapy could enhance the overall effectiveness of the treatment, providing a one-two punch against the cancer.

What evidence suggests that Liquid Nitrogen Spray Cryotherapy is effective for esophageal cancer?

Research has shown that Liquid Nitrogen Spray Cryotherapy (LNSC) effectively treats esophageal cancer. One study found that 88% of patients responded well to this treatment, with 84% experiencing complete regression, meaning the cancer and precancerous cells disappeared. In this trial, one group of participants will receive LNSC combined with standard chemotherapy, while another group will receive standard chemotherapy without LNSC. LNSC works by using extreme cold to freeze and damage cancer cells in the esophagus. It is already approved for reducing tumor size in esophageal cancer patients. Overall, LNSC has shown promising results in safely and effectively treating esophageal cancer. ^{2 3 5 6 7}

Who Is on the Research Team?

Tilak Shah, MD

Principal Investigator

Case Comprehensive Cancer Center, Cleveland Clinic Florida

Are You a Good Fit for This Trial?

This trial is for people with locally advanced esophageal adenocarcinoma who are planning to receive chemotherapy. Participants will be randomly placed into two groups, one receiving Liquid Nitrogen Spray Cryotherapy (LNSC) plus chemo and the other chemo alone.

Inclusion Criteria

I have advanced esophageal cancer and will be treated with FLOT +/- Durvalumab.

My esophageal cancer is advanced but hasn't spread to distant parts.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Liquid Nitrogen Spray Cryotherapy (LNSC) and standard of care chemotherapy, or chemotherapy alone

12 weeks

2 sessions of LNSC for the LNSC group, regular chemotherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for overall survival and systemic immune response

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Liquid Nitrogen Spray Cryotherapy

Trial Overview The study aims to assess if adding LNSC to standard chemotherapy improves treatment outcomes in esophageal adenocarcinoma compared to chemotherapy alone. LNSC involves cooling cancer cells with liquid nitrogen to damage them.

How Is the Trial Designed?

Group I: Standard of care chemotherapy Experimental Treatment 1 Intervention

Participants will receive a standard of care chemotherapy, neoadjuvant FLOT +/- durvalumab WITHOUT LNSC.

Group II: Liquid Nitrogen Spray Cryotherapy (LNSC) + Standard of care chemotherapy Experimental Treatment 2 Interventions

Participants will receive a standard of care chemotherapy, neoadjuvant FLOT +/- durvalumab WITH LNSC.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Salgi Foundation

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07222657

Liquid Nitrogen Spray Cryotherapy Prior to Neoadjuvant ... It is FDA-approved for debulking esophageal cancer. In a prospective multi-center study, we found that LNSC caused minimal side effects and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5605348/

Efficacy and safety of liquid nitrogen cryotherapy for ... Overall, 29 patients (88%) responded to cryotherapy, with 84% having complete regression of all dysplasia and cancer. Complete eradication of cancer and ...

3. journals.lww.com journals.lww.com/ajg/fulltext/9900/spray_cryotherapy_esophageal_consortium_consensus.1910.aspx

Spray Cryotherapy Esophageal Consortium Consensus... Liquid nitrogen spray cryotherapy (LNSC) is an established modality for ablation of Barrett's esophagus (BE) and esophageal cancer (EC). The ...

4. giejournal.org giejournal.org/article/S0016-5107(18)32452-0/fulltext

Tu1147 LIQUID NITROGEN SPRAY CRYOTHERAPY FOR ... A recent study with an earlier version of the current device showed effectiveness in treating esophageal cancer (EC) (Dis Esoph 2017; 30:1), but information on ...

5. withpower.com withpower.com/trial/phase-2-adenocarcinoma-of-esophagus-10-2025-ef73e

Liquid Nitrogen Spray Cryotherapy for Esophageal Cancer The purpose of this study is to compare the effectiveness of Liquid Nitrogen Spray Cryotherapy ... outcomes in esophageal adenocarcinoma ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9666080/

Safety and efficacy of liquid nitrogen spray cryotherapy in ... In patients with HGD, EET has shown to be efficacious and to have a favorable side effect profile compared to esophagectomy . Endoscopic ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510710000568

Endoscopic spray cryotherapy for esophageal cancer Conclusions. Spray cryotherapy is safe and well tolerated for esophageal cancer. Short-term results suggest that it is effective in those who could not receive ...