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Combination of TATE and PD-1 Inhibitor in Liver Cancer (TATE-PD1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259867
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : April 21, 2022
Sponsor:
Information provided by (Responsible Party):
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 Intervention/treatment Phase
Hepatocellular Carcinoma Gastric Cancer Drug: Nivolumab Injectable Product Combination Product: Trans-arterial tirapazamine embolization Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: One arm for advanced HCC, and one for second line metastatic gastro-esophageal cancer . All enrolled patients will receive the same treatment with TATE and a PD-1 inhibitor (nivolumab) until disease progression
Masking: None (Open Label)
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 : July 1, 2017
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Advanced Hepatocellular carcinoma

PD-1 inhibitor (Nivolumab 480 mg Q4W IV ) starts at day 1, and continues until progression.

TATE treatment starts at day 8 for debulking up to 4 cycles. If escape lesion appears, two more TATE treatments can be given. Tirapazamine dose at 35 mg flat dose given before embolization.

Drug: Nivolumab Injectable Product
a PD-1 immune check inhibitor
Other Name: OPDIVO

Combination Product: Trans-arterial tirapazamine embolization
Embolization with Lipiodol and Gelfoam

Experimental: Metastatic Gastro-esophageal cancer

PD-1 inhibitor (Nivolumab 480 mg Q4W IV) starts at day 1, and continues until progression.

TATE treatment starts at day 8 for debulking up to 4 cycles. If escape lesion appears, two more TATE treatments can be given. Tirapazamine dose at 35 mg flat dose given before embolization.

Drug: Nivolumab Injectable Product
a PD-1 immune check inhibitor
Other Name: OPDIVO

Combination Product: Trans-arterial tirapazamine embolization
Embolization with Lipiodol and Gelfoam




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: up to 24 months ]
    Per RECIST 1.1 criteria


Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: up to 24 months ]
    From the date of image-demonstrated response to the date of progression

  2. Time to Progression [ Time Frame: up to 24 months ]
    From randomization to disease progression or death

  3. Progression Free Survival [ Time Frame: up to 24 months ]
    From randomization to disease progression or death

  4. Overall survival [ Time Frame: through study completion, an average of 3 years ]
    From randomization to death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259867


Contacts
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Contact: Ray Lee, MD PhD 8043341076 ray.lee01@teclison.com

Locations
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United States, California
University of California, Irvine Recruiting
Orange, California, United States, 92868
Contact: Cindy D Duong         
Principal Investigator: Nadine Abi-Jaoudeh, MD         
Sponsors and Collaborators
Teclison Ltd.
Investigators
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Principal Investigator: Nadine Abi-Jaoudeh, MD UC Irvine Medical Center
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Responsible Party: Teclison Ltd.
ClinicalTrials.gov Identifier: NCT03259867    
Other Study ID Numbers: LT-004
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: April 21, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teclison Ltd.:
Hepatocellular carcinoma
Immune checkpoint inhibitor
Gastric cancer
Progression
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Stomach Neoplasms
Liver Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Nivolumab
Tirapazamine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action