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Recruiting NCT03259867

Combination of TATE and PD-1 Inhibitor in Liver Cancer

Phase II Interventional Hepatocellular Carcinoma Gastric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nivolumab Injectable Product, Trans-arterial tirapazamine embolization.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma, Gastric Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Detailed 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 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.

Interventions

  • Drug Nivolumab Injectable Product
    a PD-1 immune check inhibitor
  • Combination product Trans-arterial tirapazamine embolization
    Embolization with Lipiodol and Gelfoam

Primary outcome measures

  • Overall Response Rate [Time frame: up to 24 months]
Secondary outcome measures (4)
  • Duration of Response [Time frame: up to 24 months]
  • Time to Progression [Time frame: up to 24 months]
  • Progression Free Survival [Time frame: up to 24 months]
  • Overall survival [Time frame: through study completion, an average of 3 years]

Eligibility criteria

  • Patients with a confirmed diagnosis of (1) advanced HCC or (2) metastatic gastric cancer.
  • Patients between ages 18 and 80
  • 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.
  • 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.
  • ECOG score 2 or less
  • Child-Pugh scores 5-7 for HCC patients
  • All prior chemotherapy at least 4 weeks prior to study treatment. Immunotherapy not subject to this limitation.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • University of California, Irvine — Orange
  • University of Oklahoma Health Science Center — Oklahoma City
  • Medical College of Wisconsin — Milwaukee

Publications

  • Liu CH, Peng CM, Hwang JI, Liang PC, Chen PJ, Abi-Jaoudeh N, Giiang LH, Tyan YS. Phase I Dose-Escalation Study of Tirapazamine Chemoembolization for Unresectable Early- and Intermediate-Stage Hepatocellular Carcinoma. J Vasc Interv Radiol. 2022 Aug;33(8):926-933.e1. doi: 10.1016/j.jvir.2022.04.031. Epub 2022 Apr 30. PMID 35504436
  • Abi-Jaoudeh N, Dayyani F, Chen PJ, Fernando D, Fidelman N, Javan H, Liang PC, Hwang JI, Imagawa DK. Phase I Trial on Arterial Embolization with Hypoxia Activated Tirapazamine for Unresectable Hepatocellular Carcinoma. J Hepatocell Carcinoma. 2021 May 17;8:421-434. doi: 10.2147/JHC.S304275. eCollection 2021. PMID 34041204

Identifiers

NCT: NCT03259867 · LT-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗