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Combination of TATE and PD-1 Inhibitor in Liver Cancer
Trial Status: active
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.
Inclusion Criteria
1. Patients with a confirmed diagnosis of (1) advanced HCC or (2) metastatic gastric
cancer.
2. Patients between ages 18 and 80
3. If HCC patients, they should have progressive disease (PD) on an immune therapy for
advanced HCC. For patients with metastatic gastric cancer, they should have failed
at least one line of systemic chemotherapy and an immune checkpoint inhibitor.
4. Patients with liver tumor lesions with at least one with a diameter of 2 cm or
bigger, which is amendable for (super-)selective TATE as the target lesion.
5. ECOG score 2 or less
6. Child-Pugh scores 5-7 for HCC patients
7. All prior chemotherapy at least 4 weeks prior to study treatment. Immunotherapy not
subject to this limitation.
8. No major GI bleeding in the prior 2 months.
8. Hgb>=8, platelet >= 50,000, Cr =< 2, AST and ALT < 10 X ULN, t-Bilirubin < 3, 9.
Patients with a history of major autoimmune disorders excluded.
Additional locations may be listed on ClinicalTrials.gov for NCT03259867.
Locations matching your search criteria
United States
California
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
