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

April 15, 2026 updated by: Teclison Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • University of California, Irvine
        • Principal Investigator:
          • Nadine Abi-Jaoudeh, MD
        • Contact:
          • Miranda Duron
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Advanced Hepatocellular carcinoma

PD-1 inhibitor (Nivolumab 360 mg Q3W 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 Names:
  • OPDIVO
Combination product: Trans-arterial tirapazamine embolization
Embolization with Lipiodol and Gelfoam
Experimental: Metastatic Gastro-esophageal cancer

PD-1 inhibitor (Nivolumab 360 mg Q3W 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 Names:
  • OPDIVO
Combination product: Trans-arterial tirapazamine embolization
Embolization with Lipiodol and Gelfoam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: up to 24 months
Per RECIST 1.1 criteria
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response
Time Frame: up to 24 months
From the date of image-demonstrated response to the date of progression
up to 24 months
Time to Progression
Time Frame: up to 24 months
From randomization to disease progression or death
up to 24 months
Progression Free Survival
Time Frame: up to 24 months
From randomization to disease progression or death
up to 24 months
Overall survival
Time Frame: through study completion, an average of 3 years
From randomization to death
through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teclison Ltd.

Investigators

  • Principal Investigator: Nadine Abi-Jaoudeh, MD, UC Irvine Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

August 16, 2017

First Submitted That Met QC Criteria

August 22, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on Nivolumab Injectable Product

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe