Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Orange, California
Dates
study started
estimated completion
Principal Investigator
by Nadine Abi-Jaoudeh, MD

Description

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.

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

Details

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 gastric cancer) who have progressed on a prior immune checkpoint inhibitor 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 (Nivolumab) for abscopal effect. 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.

Keywords

Hepatocellular Carcinoma, Gastric Cancer, Immune checkpoint inhibitor, Progression, Carcinoma, Hepatocellular, Stomach Neoplasms, Liver Neoplasms, Nivolumab, Tirapazamine, Nivolumab Injectable Product, Trans-arterial tirapazamine embolization, Advanced Hepatocellular carcinoma, Metastatic Gastro-esophageal cancer

Eligibility

For people ages 18-80

  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 the first line 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 at least two 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. Alternatively, patients with one intra-hepatic lesion of 2 cm or bigger and exhapetic lesion(s) are also acceptable.
  5. ECOG score 2 or less
  6. Child-Pugh scores 5-7 for HCC patients
  7. Patients have normal organ function.

Location

  • University of California, Irvine accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Nadine Abi-Jaoudeh, MD
    Clinical Professor, Radiological Sciences, School of Medicine. Authored (or co-authored) 50 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Teclison Ltd.
ID
NCT03259867
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 54 study participants
Last Updated