This is a multi-center, open-label phase IIA study that investigates the preliminary
efficacy of Trans-arterial Tirapazamine Embolization (TATE) treatment of liver cancer
followed by a PD-1 checkpoint inhibitor (nivolumab). Patients with two types of cancers
will be enrolled, advanced hepatocellular carcinoma (HCC),and metastatic gastric cancer.
All enrolled patients need to have liver lesions and have progressed on a prior immune
checkpoint inhibitor.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03259867.
Locations matching your search criteria
United States
California
Orange
UC Irvine Health/Chao Family Comprehensive Cancer CenterStatus: Active
Contact: Jennifer D. Berg
Phone: 714-456-7687
The goal of the study is to investigate whether tumor necrosis induced by Trans-arterial
Tirapazamine Embolization (TATE) treatment can boost anti-tumor immunity and enhance the
therapeutic efficacy of immune checkpoint inhibitor. Patients with advanced liver cancers
(primary HCC or metastatic gastric cancer) who have progressed on a prior immune
checkpoint inhibitor will be enrolled in the study. Liver lesions will be treated with up
to 4 TATE treatments for optimal debulking, which also serve as a vaccination process
toward tumor. Lesion not treated with TATE will be used for monitoring the response
toward a PD-1 inhibitor (Nivolumab) for abscopal effect. If a patient subsequently
develops an "escape" to the PD-1 inhibitor, patient can have another 2 TATE treatments of
the escaped tumor lesion. Dosing of the PD-1 inhibitor is per standard FDA-approved
dosing schedule and continues until progressive disease. The efficacy will be assessed by
the response rate (RR) using RECIST.
Lead OrganizationTeclison Ltd.
