RecruitingPhase 1Phase 2NCT02174549

Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer

Phase I Dose-Escalating Study of Combining Intravenous Tirapazamine and Transarterial Embolization (TAE) in Liver Cancer


Sponsor

Teclison Ltd.

Enrollment

25 participants

Start Date

Sep 1, 2014

Study Type

INTERVENTIONAL

Conditions

Summary

This phase 1 study is to determine the optimal dose and tolerability of a hypoxia-activating agent, tirapazamine, when it is combined with embolization in liver cancer. Liver cancer patients who are Child-Pugh score A, suitable for embolization with tumor no more than 4 nodules are eligible. Tirapazamine will be given by intra-arterial injection before embolization. Treatment effect is evaluated by MRI based on mRECIST criteria. Repeat treatment is necessary only if disease progression. Dose escalation cohort has been completed. Expansion cohort is open for metastatic liver dominant neuroendocrine tumor.


Eligibility

Min Age: 20 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called tirapazamine combined with a procedure called embolization (blocking the blood supply to liver tumors) in people with neuroendocrine tumors (NETs) that have spread to the liver, to see if cutting off oxygen to the tumor while delivering this drug enhances its ability to kill cancer cells. **You may be eligible if...** - You are 20 or older with neuroendocrine tumors (slow-growing tumors) that have spread primarily to the liver - Your liver tumors have been growing despite previous treatment - The liver tumors make up less than 50% of your total liver volume - You are well enough to carry out normal activities (ECOG 0–1) - Your heart, lungs, kidneys, and blood function are at acceptable levels - You are eligible for the embolization procedure **You may NOT be eligible if...** - The main blood vessel to your liver (portal vein) is blocked - You have significant heart, lung, or kidney problems - You are pregnant or are a male partner of a woman who could become pregnant and are unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTirapazamine

Intra-arterial injection into the tumor feeding artery

PROCEDUREConventional Transarterial Embolization (TAE)

Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia


Locations(2)

Stanford University

Palo Alto, California, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT02174549


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