The goal of this clinical trial is to learn if INT001 can ablate liver tumors in adults in an outpatient setting. It will also help us learn about the safety of INT001. The main questions it aims to answer are:
1. Using a needle under image guidance, the liver tumor is accessed and INT001 is injected. Upon injection into tumor, does INT001 ablate/kill the tumor entirely?
2. What medical problems do participants experience when receiving INT001?
Participants will:
Receive INT001 on day 1. Visit the clinic day 7, 30 and 90. Receive lab tests during each visit and MRI on day 30 and 90.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Diagnosis of primary or secondary liver cancer.
✓. ECOG Performance Status score of 0 - 2
✓. Age ≥18 years, \<100 years
✓. Life expectancy of ≥3 months
✓. Patient is unsuitable for surgical resection or transplantation
✓. Ability of the patient to understand and sign the Informed Consent Form describing the study's nature
✓. Volunteer's willingness and ability to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits
Exclusion criteria
✕. Decompensated liver function, specifically Child-Pugh C, moderate to severe ascites, coagulopathy, or severe cirrhosis.
✕. Signs of liver dysfunction: AST or ALT \>5 times the upper limit of normal (ULN), Serum bilirubin level \>2.0 mg/dL
✕
What they're measuring
1
Ablation
Timeframe: MRI will be performed the day of the intervention, at 30 days and at 90 days.
✕. History of allergy or intolerance to contrast agents to be used during imaging for assessing treatment efficacy after INT001 application.
✕. Patients with life-threatening serious extrahepatic disease.
✕. 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).
✕. Significant medical or psychiatric illness.
✕. Pregnant or breastfeeding women or women planning to conceive within the next 6 months.