TACE Catheters for Liver Cancer

(Trinav Trial)

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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare CT scan of the coverage of tumors treated with TACE using End Hole catheters to those treated with the TriNav catheter that alters tissue pressure. Both catheters are FDA approved for delivery of TACE. • Is there a difference in CT appearance with delivery in the type of catheter used during the TACE procedure? Participants will be asked to undergo a TACE procedure, a CT scan and review of their medical record to compare End Hole and TriNav catheters during TACE procedures.

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 data supports the effectiveness of the treatment TACE Catheters for liver cancer?

Research shows that conventional transarterial chemoembolization (c-TACE) is a common treatment for liver cancer that cannot be surgically removed and is linked to increased overall survival compared to not treating the cancer. Additionally, TACE is widely used for both primary and metastatic liver cancers, indicating its acceptance and effectiveness in managing these conditions. ^{1 2 3 4 5}

Is TACE generally safe for humans?

TACE is generally considered safe, but it can have complications like acute cholecystitis (inflammation of the gallbladder), pulmonary embolism (blockage in the lungs), and hepatic abscess (liver infection). Most side effects are temporary and manageable, with many resolving within a week. ^{6 7 8 9 10}

How is the TACE Catheters treatment different from other liver cancer treatments?

TACE Catheters, or conventional TACE (cTACE), is unique because it delivers chemotherapy directly to the liver tumor through the arteries, using a special catheter, and then blocks the blood supply to the tumor to enhance the treatment's effect while sparing healthy liver tissue. ^{5 11 12 13 14}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

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]

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 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]

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 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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Predictors of Micrometastases in Patients with Barcelona Clinic Liver Cancer Classification B Hepatocellular Carcinoma. [2018]

2. China pubmed.ncbi.nlm.nih.gov

Long-term follow-up after conventional transarterial chemoembolization (c-TACE) with mitomycin for hepatocellular carcinoma (HCC). [2022]

3. New Zealand 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. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment outcomes for hepatocellular carcinoma using chemoembolization in combination with other therapies. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Chemoembolization for primary and metastatic liver cancer. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

Complications of transarterial chemoembolization (TACE) in the treatment of liver tumors. [2021]

7. England 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. [2021]

8. Australia pubmed.ncbi.nlm.nih.gov

Efficacy and safety of cTACE versus DEB-TACE in patients with hepatocellular carcinoma: a meta-analysis. [2022]

9. China 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. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Transarterial chemoembolization is a safe treatment for unresectable hepatic malignancies. [2015]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Epirubicin is More Effective than Miriplatin in Balloon-Occluded Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Use of the triaxial microcatheter method in super-selective transcatheter arterial chemoembolisation for hepatocellular carcinoma. [2021]

13. Egypt pubmed.ncbi.nlm.nih.gov

Prognostic Comparison between cTACE and H101-TACE in Unresectable Hepatocellular Carcinoma (HCC): A Propensity-Score Matching Analysis. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Clinical usefulness of the triaxial system in super-selective transcatheter arterial chemoembolization for hepatocellular carcinoma. [2012]