Dose-Defining Study of Tirapazamine and Embolization for Liver Cancer
This study is testing the best dose and safety of a drug called tirapazamine when combined with conventional transarterial embolization (TAE) for certain liver cancers. Tirapazamine is given by injection directly into the liver tumor's blood supply before TAE, which uses Lipiodol and Gelfoam to block blood flow to the tumor. This combination aims to create a low-oxygen environment in the tumor, which tirapazamine is designed to target. You might be able to join if you have well-differentiated neuroendocrine tumors (NET) that have spread to the liver, or other liver cancers suitable for embolization, with no more than four tumors. The main goal is to see how many patients respond to the treatment, measured by MRI scans over two years. The study is currently enrolling patients with neuroendocrine tumors.
- Study design
- This is a Phase 1 study with a 3+3 dose escalation design, meaning a small group of 3-6 patients receives increasing doses until the best dose is found. An expansion group of 15 patients will then receive this dose to check for early effectiveness.
- What's involved
- You would receive tirapazamine by intra-arterial injection, followed by embolization. Treatment effect is evaluated by MRI, and repeat treatment is only given if the disease progresses.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be measured by RECIST criteria for up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Michael Soulen, MD · PRINCIPAL_INVESTIGATOR · Univ. of Pennsylvania
Who to contact
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What this trial measures
- Overall Response rate (ORR) by RECIST2 years
Overall Response Rate by RECIST criteria