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New gel injection could zap liver tumors in a single visit

NCT ID NCT06689670

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new gel called INT001 that is injected directly into liver tumors to kill them. About 31 adults with liver cancer who cannot have surgery will receive one injection and be followed for 90 days. The goal is to see if the gel safely destroys the tumor and what side effects occur.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 31 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 100 years

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: 1. Diagnosis of primary or secondary liver cancer. 2. ECOG Performance Status score of 0 - 2 3. Age ≥18 years, \<100 years 4. Life expectancy of ≥3 months 5. Patient is unsuitable for surgical resection or transplantation 6. Ability of the patient to understand and sign the Informed Consent Form describing the study's nature 7. Volunteer's willingness and ability to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits Exclusion Criteria: 1. Decompensated liver function, specifically Child-Pugh C, moderate to severe ascites, coagulopathy, or severe cirrhosis. 2. Signs of liver dysfunction: AST or ALT \>5 times the upper limit of normal (ULN), Serum bilirubin level \>2.0 mg/dL 3. Individuals with bleeding disorders. 4. History of allergy or intolerance to contrast agents to be used during imaging for assessing treatment efficacy after INT001 application. 5. Patients with life-threatening serious extrahepatic disease. 6. Patients with concurrent conditions that, in the investigator's opinion, would prevent clinical benefit from the study procedure or could compromise patient safety or study objectives (including but not limited to ongoing infection, renal dysfunction, or morbidity). 7. Significant medical or psychiatric illness. 8. Pregnant or breastfeeding women or women planning to conceive within the next 6 months. 9. Patients participating in another study investigating a device, drug, or procedure that may impact the study treatment outcome. 10. Lesions that do not show contrast uptake on contrast-enhanced CT or MR angiography. 11. Lesions that are not hypervascular on angiography. 12. Patients who do not have CT or MR imaging available at the screening visit or are unwilling or unable to undergo MRI for various reasons during the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Koc University Hospital

    RECRUITING

    Topkapı, Istanbul, 34010, Turkey (Türkiye)

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