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Clinical Trials in the USA / NCT03259867
Recruiting Phase 2

Combination of TATE and PD-1 Inhibitor in Liver Cancer

NCT03259867 · tracked via the Priya Life Science USA tracker
Sponsor
Teclison Ltd.
Phase
Phase 2
Started
2017-07-01
Last updated
2026-04-16

Condition(s) studied

Hepatocellular CarcinomaGastric Cancer

Investigational drug(s) / intervention(s)

Nivolumab Injectable Product →Trans-arterial tirapazamine embolization

Nivolumab Injectable Product: a PD-1 immune check inhibitor

Trans-arterial tirapazamine embolization: Embolization with Lipiodol and Gelfoam

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
University of California, Irvine Orange California Recruiting
University of Oklahoma Health Science Center Oklahoma City Oklahoma Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting

More Teclison Ltd. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03259867 on ClinicalTrials.gov ↗ ← All trials in the USA