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

Primary Purpose

Hepatocellular Carcinoma, Gastric Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nivolumab Injectable Product
Trans-arterial tirapazamine embolization
Sponsored by
Teclison Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Immune checkpoint inhibitor, Gastric cancer, Progression

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  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.

Sites / Locations

  • University of California, IrvineRecruiting
  • University of Oklahoma Health Science CenterRecruiting
  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Advanced Hepatocellular carcinoma

Metastatic Gastro-esophageal cancer

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall Response Rate
Per RECIST 1.1 criteria

Secondary Outcome Measures

Duration of Response
From the date of image-demonstrated response to the date of progression
Time to Progression
From randomization to disease progression or death
Progression Free Survival
From randomization to disease progression or death
Overall survival
From randomization to death

Full Information

First Posted
August 16, 2017
Last Updated
September 18, 2023
Sponsor
Teclison Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03259867
Brief Title
Combination of TATE and PD-1 Inhibitor in Liver Cancer
Acronym
TATE-PD1
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teclison Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Gastric Cancer
Keywords
Hepatocellular carcinoma, Immune checkpoint inhibitor, Gastric cancer, Progression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Advanced Hepatocellular carcinoma
Arm Type
Experimental
Arm Description
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.
Arm Title
Metastatic Gastro-esophageal cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nivolumab Injectable Product
Other Intervention Name(s)
OPDIVO
Intervention Description
a PD-1 immune check inhibitor
Intervention Type
Combination Product
Intervention Name(s)
Trans-arterial tirapazamine embolization
Intervention Description
Embolization with Lipiodol and Gelfoam
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
Per RECIST 1.1 criteria
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Duration of Response
Description
From the date of image-demonstrated response to the date of progression
Time Frame
up to 24 months
Title
Time to Progression
Description
From randomization to disease progression or death
Time Frame
up to 24 months
Title
Progression Free Survival
Description
From randomization to disease progression or death
Time Frame
up to 24 months
Title
Overall survival
Description
From randomization to death
Time Frame
through study completion, an average of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ray Lee, MD. PhD
Phone
8043341076
Email
ray.lee01@teclison.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chiwei Lu, PhD.
Email
chiwei.lu4@teclison.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine Abi-Jaoudeh, MD
Organizational Affiliation
UC Irvine Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miranda Duron
Email
mnduron@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Nadine Abi-Jaoudeh, MD
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Yarbrough, RN
Email
melissa-yarbrough@ouhsc.edu
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Dion
Email
badion@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34041204
Citation
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.
Results Reference
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Combination of TATE and PD-1 Inhibitor in Liver Cancer

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