Combining TATE and PD-1 Inhibitor for Liver Cancer Treatment

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

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
• Enrollment: 54 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Teclison Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, Immunotherapy, nivolumab
• Locations: 3 sites (Orange, California and 2 other locations)
• Trial ID: NCT03259867 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Orange, California and 2 other locations

• 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

Conditions Hepatocellular Carcinoma; Gastric Cancer; Hepatocellular carcinoma; Immune checkpoint inhibitor; Gastric cancer; Progression