What is the mechanism of action of this treatment?

Radioembolization, including the use of Yttrium-90 (Y90) microspheres, involves delivering radioactive particles directly to the liver tumor via the hepatic artery, causing localized radiation damage to cancer cells while sparing healthy tissue. The TriNav Infusion System aims to enhance the precision of this treatment by ensuring better matching between the planning dose and the actual treatment dose, potentially improving outcomes. Transarterial chemoembolization (TACE) combines chemotherapy with embolic agents to block blood flow to the tumor, causing cell death. Systemic therapies, such as sorafenib and lenvatinib, inhibit tumor growth by targeting specific molecular pathways. These treatments are crucial for liver cancer patients as they offer targeted approaches to manage the disease, potentially improving survival and quality of life.

What side effects are associated with this type of intervention?

Common treatments for liver cancer, such as radioembolization, transarterial chemoembolization (TACE), and systemic therapies, have various side effects. Radioembolization, which involves injecting radioactive microspheres into the liver, can cause fatigue, abdominal pain, nausea, and liver dysfunction. TACE, which combines chemotherapy with embolization, often leads to postembolization syndrome characterized by fever, pain, and nausea, as well as liver enzyme elevation. Systemic therapies, including sorafenib and lenvatinib, may result in hand-foot skin reactions, diarrhea, hypertension, and fatigue. Each treatment's side effects vary in severity and frequency, necessitating careful patient monitoring.

What prior FDA approvals exist?

The FDA has approved several treatments for liver cancer, including radioembolization with Yttrium-90 (Y-90) microspheres, which is similar to the treatment being studied with the TriNav Infusion System. This system aims to enhance precision in delivering both the surrogate/test dose and the actual treatment dose during radioembolization. Additionally, sorafenib (Nexavar) and lenvatinib (Lenvima) are FDA-approved tyrosine kinase inhibitors used for advanced hepatocellular carcinoma. These drugs are often used in combination with locoregional therapies like transarterial chemoembolization (TACE) to improve treatment outcomes.

What other types of research exist?

Promising alternatives to the TriNav Infusion System for liver cancer treatment include: 1) Proton Beam Irradiation, which offers high precision and has shown high local control rates and low toxicity; 2) Transarterial Chemoembolization (TACE) combined with Radiation Therapy (RT), which has demonstrated improved response rates and survival in patients with portal vein tumor thrombosis; 3) Hepatic Arterial Infusion Chemotherapy (HAIC) using advanced infusion pumps, which allows for targeted delivery of chemotherapeutic agents with improved response rates. These alternatives provide enhanced precision and efficacy in treating liver cancer.

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TriNav Infusion System for Liver Cancer

N/A

Recruiting

Led By Armeen Mahvash, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a special tube can deliver treatment to liver tumors more accurately than usual methods. It targets patients with liver tumors who need precise treatment. The tube helps spread the medicine evenly in the liver.

Who is the study for?

This trial is for adults over 18 with inoperable liver tumors, either primary or metastatic. Participants must have a life expectancy of at least 3 months, an ECOG score ≤2 (which means they can do some activities), and not be pregnant. They should also have at least one tumor that's ≥3 cm big. People who can't undergo angiography or might get too much radiation to their lungs from the treatment cannot join.

What is being tested?

The study tests if the TriNav Infusion System improves matching between a test dose and actual radioactive microsphere distribution during radioembolization for liver cancer compared to standard catheters. It aims to see if this system leads to better planning and outcomes.

What are the potential side effects?

Possible side effects include those related to angiogram procedures like bleeding or bruising at the insertion site, allergic reactions to contrast dye, and complications from Y90-radioembolization such as fatigue, abdominal pain, nausea, fever, or potential radiation exposure risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: TriSalus™ TriNav™Infusion System (catheter)Experimental Treatment3 Interventions

TriNav Infusion System (TriNav catheter) for the injection of the surrogate/test dose during the planning part of the radioembolization procedure and your actual treatment with the radioactive microspheres match each other better than the standard catheter

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Angiogram

2021

Completed Early Phase 1

~10

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Radioembolization, including the use of Yttrium-90 (Y90) microspheres, involves delivering radioactive particles directly to the liver tumor via the hepatic artery, causing localized radiation damage to cancer cells while sparing healthy tissue. The TriNav Infusion System aims to enhance the precision of this treatment by ensuring better matching between the planning dose and the actual treatment dose, potentially improving outcomes. Transarterial chemoembolization (TACE) combines chemotherapy with embolic agents to block blood flow to the tumor, causing cell death. Systemic therapies, such as sorafenib and lenvatinib, inhibit tumor growth by targeting specific molecular pathways. These treatments are crucial for liver cancer patients as they offer targeted approaches to manage the disease, potentially improving survival and quality of life.

Therapeutic Strategies in HCC: Radiation Modalities.