Recruiting
Phase 2

TATE & PD-1 Inhibitor

Sponsor:

Teclison Ltd.

Code:

NCT03259867

Conditions

Hepatocellular Carcinoma

Gastric Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Nivolumab Injectable Product

Trans-arterial tirapazamine embolization

Study Details

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.

Conditions

Hepatocellular Carcinoma

Gastric Cancer

Study ID

NCT03259867

Start date

Jul 1, 2017

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

54 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Nivolumab Injectable Product

a PD-1 immune check inhibitor

Trans-arterial tirapazamine embolization

Embolization with Lipiodol and Gelfoam

Primary outcome measure

  • Overall Response Rate [ Time Frame: up to 24 months ]

Central Contacts and Locations

Central contacts

Ray Lee, MD. PhD

8043341076ray.lee01@teclison.com

Chiwei Lu, PhD.

chiwei.lu4@teclison.com

Locations

University of California, Irvine

Recruiting

Orange, California, United States, 92868

Contacts

mnduron@hs.uci.edu

Principal Investigator:

Nadine Abi-Jaoudeh, MD

University of Oklahoma Health Science Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Melissa Yarbrough, RN

melissa-yarbrough@ouhsc.edu

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Barbara Dion

badion@mcw.edu

More Information

Sponsor

Teclison Ltd.

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • Hepatocellular carcinoma
  • Immune checkpoint inhibitor
  • Gastric cancer
  • Progression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Teclison Ltd. on 2026-04-16.