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

NCT02174549 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Teclison Ltd.

    lead INDUSTRY

Principal Investigators

  • Michael Soulen, MD · Univ. of Pennsylvania

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2028-03-31
Completion
2028-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02174549 on ClinicalTrials.gov