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Combination of TATE and PD-1 Inhibitor in Liver Cancer

RecruitingPhase 2Ages 18 Years - 80 YearsAllTeclison Ltd.
NCT03259867 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Nivolumab Injectable Product
  • Trans-arterial tirapazamine embolization
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Where

3 sites
University of California, Irvine
Orange, United States
University of Oklahoma Health Science Center
Oklahoma City, United States
Medical College of Wisconsin
Milwaukee, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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