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Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Sponsor: Teclison Ltd.
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.
Official title: Phase I Dose-Escalating Study of Combining Intravenous Tirapazamine and Transarterial Embolization (TAE) in Liver Cancer
Key Details
Gender
All
Age Range
20 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2014-09
Completion Date
2025-12-31
Last Updated
2024-11-22
Healthy Volunteers
No
Interventions
Tirapazamine
Intra-arterial injection into the tumor feeding artery
Conventional 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