Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20-99
SponsorTeclison Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Patients with well-differentiated NET and liver-dominant metastatic disease with intrahepatic disease progression, regardless of primary tumor origin or tumor functional status. Patients may have extrahepatic lesions as long as the majority of the disease burden is intrahepatic.
No limitation in hepatic lesion tumor size or number but the total volume of liver tumors cannot exceed 50% of the liver volume.
Patients are allowed to have prior US Food and Drug Administration (FDA)-approved treatments, including systemic therapies, surgery, ablation, or transarterial therapies for the metastatic NET.
Age 20 or higher, ECOG functional status 0-1, and with no known major cardiac, pulmonary, or renal dysfunction.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Tirapazamine
- Conventional Transarterial Embolization (TAE)
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
2Stanford University94305, Palo AltoCalifornia, United States
University of Pennsylvania19104, PhiladelphiaPennsylvania, United States
Sponsors and collaborators
Teclison Ltd.
Lead sponsor
Source ClinicalTrials.gov