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NCT03259867 | RECRUITING | Hepatocellular Carcinoma

Combination of TATE and PD-1 Inhibitor in Liver Cancer
Sponsor:

Teclison Ltd.

Brief 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.

Condition or disease

Hepatocellular Carcinoma

Gastric Cancer

Intervention/treatment

Nivolumab Injectable Product

Trans-arterial tirapazamine embolization

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 54 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2017-07-01
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
    • Combination of TATE and PD-1 Inhibitor in Liver Cancer

    Location Details

    NCT03259867

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    How to Participate

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    Locations

    RECRUITING

    United States, California

    University of California, Irvine

    Orange, California, United States, 92868

    RECRUITING

    United States, Oklahola

    University of Oklahoma Health Science Center

    Ololama City, Okholohan, United States, 73104

    RECRUITING

    United States, Wisconsin

    Medical College of Wisconsin

    Milwaukee, Wisconsin, United States, 53226