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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Tirapazamine
DrugIntra-arterial injection into the tumor feeding artery
Conventional Transarterial Embolization (TAE)
Procedure/SurgeryLipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: TirapazamineExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Overall Response rate (ORR) by RECIST
Overall Response Rate by RECIST criteria
Time frame
2 yearsSecondary outcomes
1
Overall Response Rate
Overall Response Rate by mRECIST criteria
Time frame
2 years2
Duration of Response
Duration of Response by RECIST and mRECIST
Time frame
2 yearsOther outcomes
1
Response Rate in TATE-treated target lesions
by mRECIST and RECIST
Time frame
2 years2
Progressive Free Survival
by RECIST and mRECIST
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov