TACE Catheters for Liver Cancer

(Trinav Trial)

Not currently recruiting at 1 trial location

Overseen By Eric Mwaura

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Pregnancy, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two different types of catheters affect liver tumors' appearance on CT scans after a TACE procedure, which delivers medicine directly to liver tumors. The researchers aim to determine if the End Hole catheter or the TriNav catheter provides better tumor coverage. Individuals planning to undergo TACE (Transarterial Chemoembolization) for certain liver cancers, with tumors in both liver lobes, might be suitable candidates. Participants will undergo TACE procedures and CT scans to compare the effects of the two catheter types. As an unphased trial, this study allows participants to contribute to medical knowledge that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these catheters are safe for TACE procedures?

Research has shown that both the End Hole and TriNav catheters are safe for use in TACE (Transarterial Chemoembolization) procedures, as they have received FDA approval, meeting specific safety standards. One study found that the TriNav catheter led to a complete tumor response six months after treatment, indicating effectiveness without major safety issues during that period.

Real-world data also supports the safety of these catheters, demonstrating successful use in patients with liver cancer. Reports did not highlight any significant adverse events, suggesting these treatments are generally well-tolerated. However, as with any medical procedure, individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial because it explores the use of TACE catheters for liver cancer, potentially offering a more precise delivery method for treatment. Unlike traditional systemic chemotherapy, which affects the entire body, TACE (Transarterial Chemoembolization) delivers chemotherapy directly to the liver tumor through specialized catheters. This trial specifically examines the sequence of using End Hole catheters followed by TriNav catheters, and vice versa, to determine the most effective approach. By focusing on targeted delivery, these methods could enhance the concentration of the drug at the tumor site while reducing side effects, making treatment potentially more effective and tolerable for patients.

What evidence suggests that these catheters are effective for liver cancer?

In this trial, participants will receive treatment using either the End Hole Catheter followed by the TriNav Catheter or vice versa. Research has shown that both catheters effectively deliver chemotherapy during TACE, a procedure for treating liver cancer. Studies have found that using pressure, as with the TriNav Catheter, can deliver more medicine to tumors while protecting healthy tissue. The TriNav Catheter is specially designed to enhance the delivery of medicine to tumors. This method has improved liver cancer treatment by better targeting cancerous areas. Both catheters have FDA approval, and evidence supports their effectiveness in treating liver cancer. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with carcinoid tumors, liver cancer, neuroendocrine tumors, or liver tumors who are candidates for a TACE procedure. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am scheduled for a specific liver cancer treatment using lipiodol.

My liver cancer requires multiple targeted treatments.

Less than half of my liver is affected by cancer.

Exclusion Criteria

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Pregnancy or lactation

I cannot have iodine-based contrast due to a severe past reaction.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a TACE procedure using either End Hole or TriNav catheters, followed by a CT scan to assess lipiodol deposition

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the TACE procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TACE Catheters

Trial Overview

The study aims to compare the effectiveness of two FDA-approved catheters (End Hole and TriNav) used in TACE procedures by examining CT scans to see how well each covers the treated tumors.

How Is the Trial Designed?

Group I: TriNav Catheter followed by End Hole Catheter Experimental Treatment 1 Intervention

FDA approved catheter Randomization TriNav catheter then End Hold catheter

Group II: End Hole Catheter followed by TriNav Catheter Experimental Treatment 1 Intervention

FDA approved catheter Randomization End Hole catheter then TriNav catheter

TACE Catheters is already approved in European Union, United States for the following indications:

Approved in European Union as TACE for:

• Hepatocellular carcinoma (HCC)
• Liver metastases from gastroenteropancreatic neuroendocrine tumors

Approved in United States as TACE for:

• Hepatocellular carcinoma (HCC)
• Liver metastases from gastroenteropancreatic neuroendocrine tumors

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

TriSalus Life Sciences

Collaborator

Trials

5

Recruited

70+

TriSalus Life Sciences, Inc.

Industry Sponsor

Trials

10

Recruited

420+

Published Research Related to This Trial

In a study of 876 patients with hepatocellular cancer (HCC) undergoing liver transplantation, transarterial chemoembolization (TACE) did not increase the risk of postoperative hepatic artery complications compared to those who did not receive TACE.

The analysis of intraoperative interventions also showed no significant difference in the need for hepatic artery interventions between patients who underwent TACE and those who did not, indicating that TACE is a safe option before liver transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transarterial chemoembolization of hepatocellular carcinoma before liver transplantation and risk of post-transplant vascular complications: a multicentre observational cohort and propensity score-matched analysis. Sneiders, D., Boteon, APCS., Lerut, J., et al.[2021]

In a study of 111 patients with unresectable hepatocellular carcinoma (HCC), transarterial infusion of recombinant human type-5 adenovirus (H101-TACE) showed a significantly longer overall survival (OS) of 22.1 months compared to 13.1 months for conventional TACE (cTACE).

H101-TACE also demonstrated improved progression-free survival (PFS) and a higher disease control rate (81.1% vs. 59.5%) compared to cTACE, indicating that H101-TACE is both safe and more effective for treating unresectable HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic Comparison between cTACE and H101-TACE in Unresectable Hepatocellular Carcinoma (HCC): A Propensity-Score Matching Analysis. Yao, M., Cheng, S., Zhai, X., et al.[2022]

Transarterial chemoembolization (TACE) is a generally safe and effective treatment for liver tumors, with a low incidence of major complications, including acute cholecystitis and acute pancreatitis, observed in a study of 196 patients over four years.

The study identified concomitant cardiovascular disease as a significant risk factor for complications following TACE, highlighting the importance of patient assessment before the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of transarterial chemoembolization (TACE) in the treatment of liver tumors. Marcacuzco Quinto, A., Nutu, OA., San Román Manso, R., et al.[2021]

In a study of 40 patients with early-stage hepatocellular carcinoma (HCC), drug-eluting bead TACE (DEB-TACE) showed a slightly better tumor response compared to conventional transarterial chemoembolization (cTACE), suggesting it may be a more effective initial treatment option.

While both treatments had similar rates of serious complications, the DEB-TACE group had a significantly higher conversion rate to other treatment modalities (40% vs. 10% for cTACE) after one year, indicating potential challenges in managing HCC with DEB-TACE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of tumor response following conventional versus drug-eluting bead transarterial chemoembolization in early- and very early-stage hepatocellular carcinoma. Razi, M., Safiullah, S., Gu, J., et al.[2022]

In a study of 35 patients with intermediate hepatocellular carcinoma (HCC) treated with balloon-occluded transcatheter arterial chemoembolization (B-TACE), the use of epirubicin significantly improved the time to progression (TTP) compared to miriplatin, with TTP of 15.1 months versus 3.2 months, respectively.

Achieving complete tumor necrosis (TE4) was identified as a key factor for better TTP after B-TACE, indicating that epirubicin is a more effective drug for this treatment compared to miriplatin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epirubicin is More Effective than Miriplatin in Balloon-Occluded Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma. Shirono, T., Iwamoto, H., Niizeki, T., et al.[2019]

Transarterial chemoembolization (TACE) was safely performed on 15 patients with hepatic malignancies, with no cases of acute liver failure reported, and most adverse effects were transient and resolved within a week.

The treatment led to a significant decrease in tumor markers in 10 out of 13 patients, and the overall survival rate was 93% over a median follow-up of 10 months, indicating its efficacy in managing hepatic tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transarterial chemoembolization is a safe treatment for unresectable hepatic malignancies. Lopez, RR., Pan, SH., Lois, JF., et al.[2015]

In a study of 60 patients with unresectable hepatocellular carcinoma treated with conventional transarterial chemoembolization (c-TACE) using mitomycin, the overall survival rates were 72.1% at 1 year, 47.8% at 3 years, and 39.3% at 5 years, indicating the treatment's effectiveness over the long term.

Patients who achieved an objective tumor response (complete or partial response) had a significantly lower risk of death compared to those with progressive disease, highlighting the importance of treatment response in predicting patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up after conventional transarterial chemoembolization (c-TACE) with mitomycin for hepatocellular carcinoma (HCC). Yamada, R., Bassaco, B., Bracewell, S., et al.[2022]

In a study of 138 patients with hepatocellular carcinoma (HCC), trans-arterial radioembolization (TARE) demonstrated significantly better overall survival (OS) and progression-free survival (PFS) compared to conventional trans-arterial chemoembolization (TACE).

TARE was found to be an independent prognostic factor for improved clinical outcomes, with a hazard ratio indicating a 48% reduction in the risk of death compared to TACE, highlighting its efficacy as an initial treatment option for HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yttrium-90 Radioembolization Is Associated with Better Clinical Outcomes in Patients with Hepatocellular Carcinoma Compared with Conventional Chemoembolization: A Propensity Score-Matched Study. Kim, MA., Jang, H., Choi, NR., et al.[2022]

Transcatheter arterial chemoembolization (TACE) is a widely used procedure for palliative treatment of liver cancers, both primary and metastatic, highlighting its importance in interventional radiology.

The newer method of TACE using drug-eluting microspheres is gaining popularity and may offer improved outcomes, indicating a promising direction for future cancer treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemoembolization for primary and metastatic liver cancer. Liapi, E., Geschwind, JF.[2022]

The triaxial microcatheter method significantly improved the ability to advance the catheter tip closer to hepatocellular carcinoma (HCC) during transcatheter arterial chemoembolisation (TACE), achieving successful catheter placement in 93% of procedures evaluated (28 out of 30).

This new technique allowed for more precise embolisation levels, with 13 cases achieving sub-subsegmental embolisation compared to only 1 case with conventional microcatheters, enhancing the treatment's effectiveness while minimizing damage to healthy liver tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the triaxial microcatheter method in super-selective transcatheter arterial chemoembolisation for hepatocellular carcinoma. Shimohira, M., Ogino, H., Kawai, T., et al.[2021]

In a study of 38 patients with resectable BCLC stage B hepatocellular carcinoma (HCC), elevated levels of α-fetoprotein (AFP) and prothrombin induced by vitamin K absence-II (PIVKA-II) were identified as significant predictors of micrometastases and poor survival outcomes after surgical resection.

Validation in a separate group of 54 patients undergoing transarterial chemoembolization (TACE) showed that those with AFP <110 and PIVKA-II <800 had significantly better survival rates, suggesting these biomarkers can help identify patients who would benefit most from surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Micrometastases in Patients with Barcelona Clinic Liver Cancer Classification B Hepatocellular Carcinoma. Suh, SW., Choi, YS.[2018]

In a study of 63 patients with hepatocellular carcinoma (HCC), the use of a new triaxial microcatheter system for super-selective transcatheter arterial chemoembolization (TACE) resulted in significantly higher local tumor control rates compared to a conventional system, with rates of 64% at 3 months versus 40% in the control group.

The triaxial system demonstrated safety with no major complications reported, suggesting it is a promising option for improving treatment outcomes in patients with small HCCs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical usefulness of the triaxial system in super-selective transcatheter arterial chemoembolization for hepatocellular carcinoma. Shimohira, M., Ogino, H., Kawai, T., et al.[2012]

Drug-eluting bead transarterial chemo-embolization (DEB-TACE) significantly improves the complete response rate and overall survival rate in patients with hepatocellular carcinoma (HCC) compared to conventional transarterial chemo-embolization (cTACE), based on a meta-analysis of studies published from 1990 to 2015.

DEB-TACE is associated with fewer adverse events than cTACE, indicating it may be a safer option for patients undergoing treatment for HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of cTACE versus DEB-TACE in patients with hepatocellular carcinoma: a meta-analysis. Zou, JH., Zhang, L., Ren, ZG., et al.[2022]

A meta-analysis of 4 randomized controlled trials showed that combining transarterial chemoembolization (TACE) with percutaneous ablation significantly reduces mortality in patients with hepatocellular carcinoma (HCC), regardless of tumor size.

Transarterial injection of chemotherapeutic drugs mixed with lipiodol (TOCE) after liver surgery improves survival and reduces tumor recurrence, highlighting the benefits of a multimodal treatment approach for HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment outcomes for hepatocellular carcinoma using chemoembolization in combination with other therapies. Marelli, L., Stigliano, R., Triantos, C., et al.[2014]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6394778/

End-hole Versus Microvalve Infusion Catheters in Patients ...

Transarterial chemoembolization (TACE) is effective in bridging patients to liver transplantation for patients with hepatocellular carcinoma ( ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06204159?cond=liver%20tumor&aggFilters=status:,phase

Lipiodol Deposition Using Endhole vs. Pressure ...

End Hole and TriNav catheters are FDA approved. This study is comparing the two for chemotherapy delivery during the TACE procedure.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1051044324007206

Pressure-Enabled Drug Delivery Significantly Increases ...

These findings demonstrate significantly enhanced tumor delivery of microspheres with improved sparing of normal tissue (increased T/N ratio) when delivered ...

4.

tandfonline.com

tandfonline.com/doi/full/10.1080/03007995.2024.2322057

Real-world evidence of Pressure-Enabled Drug Delivery ...

A method using pressure to advance catheter-delivered drug distribution, can improve treatment for hepatocellular carcinoma (HCC) and liver metastases.

5.

trisaluslifesci.com

trisaluslifesci.com/recent-news/trisalus-life-sciences-launches-the-new-trinav-infusion-system-an-innovative-solution-designed-to-overcome-infusion-barriers-within-solid-tumors/

TriSalus Life Sciences Launches the New TriNav ...

TriNav is designed to help overcome the infusion barriers that limit therapeutic uptake in solid tumors, including hepatocellular carcinoma (HCC) and liver ...

6.

trinavinfusion.com

trinavinfusion.com/wp-content/uploads/TriNav_Email_ElevatingTace.pdf

Elevating TACE Outcomes with TriNav

After treatment with TriNav, complete tumor response was achieved at the 6-month follow- up. This case demonstrates how the PEDD approach can enhance ...

7.

investors.trisaluslifesci.com

investors.trisaluslifesci.com/news-releases/news-release-details/trisalus-life-sciences-announces-real-world-data-demonstrating

Release Details

The data presented in this study captured real-world safety and clinical outcomes data ... outcomes in liver cancer patients. The ability ...