AzTrials
AzTrials

Hepatocellular CarcinomaPhase 2TATE-PD1NCT03259867

Combination of TATE and PD-1 Inhibitor in Liver Cancer

A Phase 2 study testing Nivolumab Injectable Product and Trans-arterial tirapazamine embolization in people with Hepatocellular Carcinoma and Gastric Cancer, run by Teclison Ltd. at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hepatocellular Carcinoma, Gastric Cancer
What is being tested?
Nivolumab Injectable Product and Trans-arterial tirapazamine embolization
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
3 sitesUnited States
Study dates
1 Jul 2017to 30 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  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.
  9. 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ray Lee, MD. PhD contact

8043341076

ray.lee01@teclison.com

Chiwei Lu, PhD. contact

chiwei.lu4@teclison.com

United States3 sites, 3 recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Barbara Dion, badion@mcw.edu

    Recruiting

  • University of Oklahoma Health Science Center

    Oklahoma City, Oklahoma, 73104

    Melissa Yarbrough, RN, melissa-yarbrough@ouhsc.edu

    Recruiting

  • University of California, Irvine

    Orange, California, 92868

    Miranda Duron

    mnduron@hs.uci.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Nivolumab Injectable Product, Trans-arterial tirapazamine embolization
Keywords
Hepatocellular carcinoma, Immune checkpoint inhibitor, Gastric cancer, Progression
Medical subject headings
Carcinoma, Hepatocellular, Stomach Neoplasms, Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nivolumab Injectable ProductDrug

    Also called OPDIVO

    a PD-1 immune check inhibitor

  • Trans-arterial tirapazamine embolizationCombination product

    Embolization with Lipiodol and Gelfoam

Study groups in NCT03259867
Study groupRoleWhat they receive
Advanced Hepatocellular carcinomaExperimentalPD-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.
Receives: Drug: Nivolumab Injectable Product; Combination Product: Trans-arterial tirapazamine embolization
Metastatic Gastro-esophageal cancerExperimentalPD-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.
Receives: Drug: Nivolumab Injectable Product; Combination Product: Trans-arterial tirapazamine embolization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    Per RECIST 1.1 criteria

    Measured: up to 24 months

Secondary outcomes (4)

  1. Duration of Response

    From the date of image-demonstrated response to the date of progression

    Measured: up to 24 months

  2. Time to Progression

    From randomization to disease progression or death

    Measured: up to 24 months

  3. Progression Free Survival

    From randomization to disease progression or death

    Measured: up to 24 months

  4. Overall survival

    From randomization to death

    Measured: through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2017
  2. Study start1 Jul 2017
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
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)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03259867
Sponsor's protocol ID
LT-004
Acronym
TATE-PD1
Status last verified
Apr 2026
First submitted
16 Aug 2017
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu CH, Peng CM, Hwang JI, Liang PC, Chen PJ, Abi-Jaoudeh N, Giiang LH, Tyan YS. Phase I Dose-Escalation Study of Tirapazamine Chemoembolization for Unresectable Early- and Intermediate-Stage Hepatocellular Carcinoma. J Vasc Interv Radiol. 2022 Aug;33(8):926-933.e1. doi: 10.1016/j.jvir.2022.04.031. Epub 2022 Apr 30.

    PubMed 35504436

  • 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.

    PubMed 34041204

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab Injectable Product and Trans-arterial tirapazamine embolization in people with Hepatocellular Carcinoma and Gastric Cancer, run by Teclison Ltd. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ray Lee, MD. PhD (8043341076, ray.lee01@teclison.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03259867, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in