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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

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate

Secondary study objectives

Duration of Response

Overall survival

Progression Free Survival

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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