RecruitingPhase 2NCT03259867

Combination of TATE and PD-1 Inhibitor in Liver Cancer

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.

Enrollment

54 participants

Start Date

Jul 1, 2017

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer Hepatocellular Carcinoma

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a targeted liver procedure (TATE — a way of delivering heat and particles directly to liver tumors through blood vessels) with an immunotherapy drug (a PD-1 inhibitor that helps the immune system fight cancer) improves outcomes for people with advanced liver cancer or stomach cancer that has spread to the liver. **You may be eligible if...** - You have advanced liver cancer (hepatocellular carcinoma, or HCC) or stomach cancer that has spread to other organs - You are between 18 and 80 years old - You have at least one liver tumor that is 2 cm or larger - Your cancer has progressed despite previous treatment with immunotherapy (for liver cancer) or chemotherapy and immunotherapy (for stomach cancer) - You are in reasonable physical condition (ECOG score of 2 or less) **You may NOT be eligible if...** - You have had a major gastrointestinal bleed in the past 2 months - You have significantly abnormal blood counts, liver function, or kidney function - You have a history of major autoimmune disorders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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