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Freezing tumors to boost cancer treatment: early trial underway

NCT ID NCT04248582

Disease control Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This early-phase trial tests a freezing treatment called cryotherapy, given before and during standard chemoradiation, for people with locally advanced esophageal cancer. The main goal is to find the safest number of cryotherapy sessions. Researchers will also check if the freezing stimulates the immune system to fight the tumor better. Only 14 adults are taking part, so results are very preliminary.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cryotherapy (liquid nitrogen spray)
What this could lead to
If successful, this could point toward a way to improve the effectiveness of standard chemoradiation for esophageal cancer by boosting the immune response.
What could go wrong
This is a very early Phase 1 trial with only 14 participants, focused on safety and dosing. It is not designed to prove the treatment works, and the cryotherapy may cause side effects like pain or damage to the esophagus.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

14 people

The number who actually took part.

Started

Feb 2020

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Adult patients with locally advanced esophageal cancer will be eligible to participate in the study. Eligible patients must have a histologically proven diagnosis of esophageal adenocarcinoma, esophageal squamous cell carcinoma, adenosquamous carcinoma, or gastro-esophageal junctional adenocarcinoma. Locally advanced esophageal cancer will be defined as absence of distant metastases on positron emission tomography-computed tomography (PET-CT) and a TNM stage of IIA to IIIC, as defined by endoscopic ultrasound and PET-CT Exclusion Criteria: 1. Pediatric patients (age less than 18 years) 2. Superficial esophageal cancer 3. Inability to pass the orogastric decompression tube into the stomach 4. Coagulopathy (INR \> 2 or platelet count \< 50,000/cubic millimeter). 5. Inability to provide informed consent 6. Eastern Cooperative Oncology Group (ECOG) performance status ≥3 7. Pregnancy

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Conditions

The condition(s) this trial relates to.

adenosquamous carcinoma esophageal adenocarcinoma esophageal adenosquamous carcinoma esophageal cancer Esophageal Neoplasms esophageal squamous cell carcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal cancer

Contacts and locations

Locations

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249, United States

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