At a glance
ClinicalIndex Comparison Record- ✓Well-differentiated NET with liver-dominant metastatic disease and intrahepatic disease progression
- ✓Majority of disease burden intrahepatic; extrahepatic lesions allowed
- ✓Total liver tumor volume cannot exceed 50% of liver volume
- ✓Prior FDA-approved treatments allowed including systemic therapies, surgery, ablation, or transarterial therapies
- ✕Portal vein occlusion
- ✕Known major cardiac, pulmonary, or renal dysfunction
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Dose-Escalating Study of Combining Intravenous Tirapazamine and Transarterial Embolization (TAE) in Liver Cancer
In Brief
A Phase 2 clinical trial evaluating Tirapazamine and Conventional Transarterial Embolization (TAE) for Hepatocellular Carcinoma and 2 related conditions. Currently recruiting, targeting 25 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Intra-arterial injection into the tumor feeding artery
Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia