Combining TATE and PD-1 Inhibitor for Liver Cancer Treatment
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
Run by Teclison Ltd. · NCT03259867 · Data updated 2026-11-12
This study is testing if combining a new liver cancer treatment called TATE with a drug that boosts the immune system, nivolumab, can help people with advanced liver cancer and metastatic gastric cancer feel better and fight their disease more effectively.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | Teclison Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, Immunotherapy, nivolumab |
| Locations | 3 sites (Orange, California and 2 other locations) |
| Status | Recruiting |
| Started | July 1, 2017 |
| Main results expected | December 30, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT03259867 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 to 80 with advanced HCC or metastatic gastric cancer who have progressed on prior immune checkpoint inhibitors.
✕Probably not a fit
Patients with major autoimmune disorders or those who have experienced major gastrointestinal bleeding in the past two months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi-center, open-label phase IIA study evaluates the effectiveness of Trans-arterial Tirapazamine Embolization (TATE) followed by the PD-1 inhibitor nivolumab in patients with advanced hepatocellular carcinoma (HCC) and metastatic gastric cancer. The study aims to determine if TATE can induce tumor necrosis that enhances the immune response against cancer, thereby improving the efficacy of nivolumab. Patients will receive up to four TATE treatments to debulk liver lesions, which will also serve as a vaccination process. The response to nivolumab will be monitored, and additional TATE treatments may be administered if the cancer escapes treatment. Efficacy will be assessed using the response rate based on RECIST criteria.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with advanced liver cancers who have limited options.
How similar studies have gone: While the combination of TATE and PD-1 inhibitors is a novel approach, similar studies involving immune checkpoint inhibitors have shown promising results in other cancer types.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
University of California, Irvine
Orange, California, United States Recruiting -
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States Recruiting -
Medical College of Wisconsin
Milwaukee, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Nadine Abi-Jaoudeh, MD — UC Irvine Medical Center
- Study coordinator: Ray Lee, MD. PhD
- Email: ray.lee01@teclison.com
- Phone: 8043341076
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.