NCT02174549

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Teclison Ltd. · Industry
• Sex: All
• Age: 20 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is a 3+3 design for dose escalation. Each cohort will have 3-6 patients based on tolerability. Patients will receive escalated doses of tirapazamine until maximally tolerated dose. Embolization is performed per standard practice using Lipiodol and Gelfoam under X-ray guidance. Once a suitable dose is determined, an expansion cohort of 15 patients will be treated with the recommended phase 2 dose to determine preliminary efficacy. Expansion cohorts include (1) hepatocellular carcinoma, (2) metastatic solid tumors with liver metastasis, and (3) neuroendocrine tumor. Adverse events are evaluated by CTCAE vs. 5.0 and efficacy is evaluated by MRI using modified RECIST criteria and RECIST criteria. The dose escalation part has been completed. Only the third cohort or neuroendocrine tumor remains active for future patient enrollment.

Conditions

• Hepatocellular Carcinoma
• Gastrointestinal Cancer Metastatic
• Neuroendocrine Tumors

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-09-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2014-06-25
• Last updated: 2024-11-22

Locations

2 sites across 1 country: United States