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PD-1 Inhibitor

TATE + PD-1 Inhibitor for Liver Cancer (TATE-PD1 Trial)

Phase 2

Recruiting

Led By Nadine Abi-Jaoudeh, MD

Research Sponsored by Teclison Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HCC patients with progressive disease on immune therapy or metastatic gastric cancer patients who 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, amendable for (super-)selective TATE as the target lesion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 3 years

Awards & highlights

TATE-PD1 Trial Summary

This trial is testing a new treatment for liver cancer that involves using a PD-1 checkpoint inhibitor drug after Trans-arterial Tirapazamine Embolization (TATE) treatment.

Who is the study for?

This trial is for adults aged 18-80 with advanced liver cancer (HCC) or metastatic stomach cancer, who have not responded to prior immune therapy. HCC patients must have a Child-Pugh score of 5-7 and all participants should be relatively fit (ECOG score ≤2), with normal organ function and at least one treatable liver tumor.Check my eligibility

What is being tested?

The study tests TATE, a targeted liver cancer treatment, followed by Nivolumab, an immunotherapy drug. It's designed to see how well these treatments work together in patients with specific types of advanced or metastatic cancers that affect the liver.See study design

What are the potential side effects?

Possible side effects include typical reactions from embolization like abdominal pain and fever, as well as those related to Nivolumab such as fatigue, skin issues, respiratory problems, and potential immune-related complications.

TATE-PD1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver or stomach cancer has worsened despite immune therapy.

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I have a liver tumor larger than 2 cm suitable for targeted therapy.

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I can take care of myself but cannot do heavy physical work.

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My liver function is moderately impaired.

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I am between 18 and 80 years old.

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I have been diagnosed with advanced liver cancer or cancer that has spread from my stomach.

TATE-PD1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate

Secondary outcome measures

Duration of Response

Overall survival

Progression Free Survival

+1 more

TATE-PD1 Trial Design

2Treatment groups

Experimental Treatment

Group I: Metastatic Gastro-esophageal cancerExperimental Treatment2 Interventions

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.

Group II: Advanced Hepatocellular carcinomaExperimental Treatment2 Interventions

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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Teclison Ltd.Lead Sponsor

3 Previous Clinical Trials

269 Total Patients Enrolled

Nadine Abi-Jaoudeh, MDPrincipal InvestigatorUC Irvine Medical Center

4 Previous Clinical Trials

174 Total Patients Enrolled

1 Trials studying Liver Cancer

Media Library

Nivolumab Injectable Product (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03259867 — Phase 2

Liver Cancer Research Study Groups: Advanced Hepatocellular carcinoma, Metastatic Gastro-esophageal cancer

Liver Cancer Clinical Trial 2023: Nivolumab Injectable Product Highlights & Side Effects. Trial Name: NCT03259867 — Phase 2

Nivolumab Injectable Product (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03259867 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have signed up for this clinical trial thus far?

"The trial is recruiting patients as of the most recent update on clinicaltrials.gov, which was edited on 4/13/2022. The study was first posted on 7/1/2017 and is looking for 54 participants across 1 site."

Answered by AI

For which patients is this research project meant?

"This clinical trial is seeking 54 individuals that have been diagnosed with colorectal cancer. Furthermore, these patients must meet the following requirements: be between the ages of 18 and 80, have two liver tumor lesions with one being 2 cm or larger in diameter, an ECOG score of 2 or less, Child-Pugh scores of 5-7 for HCC patients, normal organ function, and 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"

Answered by AI

What is the usual reason that doctors use Trans-arterial tirapazamine embolization?

"Trans-arterial tirapazamine embolization can be used as a treatment method for various conditions such as unresectable melanoma, microsatellite instability high, and squamous cell carcinoma."

Answered by AI

Is the Trans-arterial tirapazamine embolization procedure dangerous for patients?

"Trans-arterial tirapazamine embolization has not been proven effective, however, there is data supporting its safety which earns it a score of 2."

Answered by AI

Is this the first time Trans-arterial tirapazamine embolization has been used in a clinical trial?

"As of right now, there are 1,701 ongoing clinical trials related to Trans-arterial tirapazamine embolization. Out of these, 200 are in Phase 3. The majority of the trials for Trans-arterial tirapazamine embolization are located in Houston, Texas; however, there are a total of 73,374 locations across the globe where clinical trials for this treatment are taking place."

Answered by AI

Are geriatric patients being included in this research?

"The age requirements to participate in this trial are between 18-80 years old."

Answered by AI

Are there any open positions for candidates in this trial?

"According to the clinicaltrials.gov listing, this is an ongoing trial that has been recruiting since July 1st, 2017. The 54 participants are needed from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination of TATE and PD-1 Inhibitor in Liver Cancer

2017. "Combination of TATE and PD-1 Inhibitor in Liver Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03259867.

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