Last updated on July 2018

Combination of TATE and PD-1 Inhibitor in Liver Cancer

Brief description of study

This is a single 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 (either nivolumab or pembrolizumab). Patients with four types of cancers will be enrolled, hepatocellular carcinoma (HCC), metastatic colorectal cancer (mCRC), metastatic gastric cancer and advanced non-small cell lung cancer. All enrolled patients need to have liver lesions.

Detailed Study 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 of immune checkpoint inhibitor. Patients with advanced liver cancers (primary HCC or metastatic liver cancer derived from colorectal, gastric and NSCLC) will be enrolled in the study. Liver lesions will be treated with up to 4 TATE treatments for optimal debulking, which also serve as a vaccination process toward tumor. Lesion not treated with TATE will be used for monitoring the response toward a PD-1 inhibitor (either Nivolumab or Pembrolizumab per investigator decision). If a patient subsequently develops an "escape" to the PD-1 inhibitor, patient can have another 2 TATE treatments of the escaped tumor lesion. Dosing of the PD-1 inhibitor is per standard FDA-approved dosing schedule and continues until progressive disease. The efficacy will be assessed by the response rate (RR) using RECIST and irRC for the non-TATE treated lesion, and compared with the historic RR of the PD-1 inhibitor in HCC (~16%) and mCRC (almost 0% for those without mismatch repair defect), advanced gastric cancer (15%) and metastatic NSCLC who failed to respond to an immune checkpoint inhibitor.

Clinical Study Identifier: NCT03259867

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Nadine Abi-Jaoudeh, MD

University of California, Irvine
Orange, CA United States
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