Status:
RECRUITING
Combination of TATE and PD-1 Inhibitor in Liver Cancer
Lead Sponsor:
Teclison Ltd.
Conditions:
Hepatocellular Carcinoma
Gastric Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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...
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- Patients with a confirmed diagnosis of (1) advanced HCC or (2) metastatic gastric cancer.
- Patients between ages 18 and 80
- 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.
- 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.
- ECOG score 2 or less
- Child-Pugh scores 5-7 for HCC patients
- All prior chemotherapy at least 4 weeks prior to study treatment. Immunotherapy not subject to this limitation.
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03259867
Start Date
July 1 2017
End Date
December 31 2025
Last Update
November 22 2024
Active Locations (3)
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1
University of California, Irvine
Orange, California, United States, 92868
2
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
3
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226