New gel injection could zap liver tumors in a single visit
NCT ID NCT06689670
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HCC - hepatocellular carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGTopkapı, Istanbul, 34010, Turkey (Türkiye)
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a website help liver cancer patients care for themselves during chemoembolization?
- Can removing the spleen help the liver fight cancer?
- Liver cancer treatments under Real-World scrutiny
- Can protein patterns in stored tumors point to new treatment targets?
- A smarter way to choose liver cancer treatment? a new model aims to match therapy to the patient.
- Can a Three-Pronged attack shrink liver tumors before surgery?