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RECRUITING
NCT02174549
PHASE1/PHASE2

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

Sponsor: Teclison Ltd.

View on ClinicalTrials.gov

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

DRUG

Tirapazamine

Intra-arterial injection into the tumor feeding artery

PROCEDURE

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