What this study is
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.
What's being tested
- Nivolumab Injectable Product
Intervention · DRUG
a PD-1 immune check inhibitor
- Trans-arterial tirapazamine embolization
Intervention · COMBINATION PRODUCT
Embolization with Lipiodol and Gelfoam
Study details
- Official title
- Phase IIA Single-Arm Study of Treatment of Patients With Advanced Liver Cancer With a Combination of TATE (Transarterial Tirapazamine Embolization) Followed by an Anti-PD-1 Monoclonal Antibody
- Sponsor
- Teclison Ltd.
- Conditions
- Hepatocellular Carcinoma · Gastric Cancer
- Enrolling
- 54 people
- Starts
- 2017-07-01
- Est. completion
- 2025-12-31
- Design
- Open-label, non-randomized, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openUniversity of California, Irvine
Orange, California, United States
- Miranda Duron · Contact
- Contactmnduron@hs.uci.edu
- Nadine Abi-Jaoudeh, MD · Principal investigator
RecruitingUniversity of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
- Melissa Yarbrough, RN · Contactmelissa-yarbrough@ouhsc.edu
Recruiting- Recruiting
Study team
Sponsor
Teclison Ltd.
Study ID LT-004
Principal investigator
Nadine Abi-Jaoudeh, MD
UC Irvine Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.