Role of DEB-TACE Versus c-TACE in Treatment of HCC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hepatocellular carcinoma (HCC) is listed as the sixth most common cancer worldwide and the third most frequent cause of cancer-related mortality. The majority of HCC cases occurs stem from chronic liver disease and cirrhosis.

Hepatocellular carcinoma accounts for approximately 70% to 90% of all primary liver cancers. Trans-arterial Chemoembolization is the most widely utilized and is considered the first-line treatment recommended for patients staged as intermediate HCC (Barcelona Clinic Liver Cancer stage B). If applied correctly, TACE can produce survival benefits without adversely affecting hepatic functional reserve.

Two TACE techniques have been used since 2004, conventional TACE (c-TACE) and TACE with drug-eluting beads (DEB-TACE). Conventional TACE was evidenced first to treat intermediate stage HCC patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DEB-TACE+HAIC vs. HAIC for Large HCC

NCT05263219

Unresectable Hepatocellular Carcinoma

RECRUITING PHASE3

Transarterial Radioembolization Versus Chemoembolization for the Treatment of Hepatocellular Carcinoma

NCT02729506

Hepatocellular Carcinoma

UNKNOWN PHASE4

The Comparison Between HepaSphere Drug-eluting Bead Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma

NCT05862181

Advanced Hepatocellular Carcinoma (HCC)

UNKNOWN

Safety and Efficacy of DEB-TACE Performed With a Novel Reflux-control Microcatheter in Patients With HCC

NCT04653701

Hepatocellular Carcinoma Liver Cancer

UNKNOWN

DEB-TACE vs. cTACE as Conversion Therapy for Unresectable Large HCC

NCT04967482

Hepatocellular Carcinoma Non-resectable

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hepatocellular carcinoma (HCC) is listed as the sixth most common cancer worldwide and the third most frequent cause of cancer-related mortality. The majority of HCC cases occurs stem from chronic liver disease and cirrhosis.

Hepatocellular carcinoma accounts for approximately 70% to 90% of all primary liver cancers. HCC patients have been suffering from poor prognosis with 5-year survival being roughly 10% to 15% for decades despite the progress in screening, diagnosis, and treatment, which is mainly resulted from that most patients are already in the moderate or advanced stage at diagnosis, whom can only receive palliative treatments.

At the level of the individual patient, concomitant cirrhosis and the number, size, and location of hepatocellular tumors will affect the treatment approach. In addition, multiple disease-related factors need to be taken into account, such as the presence of vascular involvement or extra-hepatic disease, when deciding on the best treatment options for these patients. Consequently, a multidisciplinary approach involving several physicians with different specialties (e.g., diagnostic and interventional radiologists, surgical oncologists, hepatologists, and medical oncologists) is necessary to determine the best approach to treatment and maximize potential outcomes for patients with HCC.

The liver has a dual vascular supply via the hepatic artery and the portal vein. The rationale of the trans-arterial embolotherapies is explained by the fact that liver malignancies are predominantly supplied by the hepatic artery, which allows delivering the chemotherapy directly to the tumor-feeding artery while sparing the healthy hepatic tissue mainly supplied by the portal vein.

Loco regional treatments are a set of therapeutic approaches that directly target tumors in the liver. Among the loco regional modalities, trans-arterial chemoembolization (TACE) involves the local delivery of chemotherapy to the tumor and is generally recommended for patients with liver-limited disease. Several randomized trials have been conducted to examine the efficacy and safety of TACE.

According to the Barcelona Clinic Liver Cancer (BCLC) staging system, TACE is the first-line treatment for patients with intermediate stage HCC, including those with large or multinodular HCC, well-preserved liver function, and no cancer-related symptoms or evidence of vascular invasion or extrahepatic spread. Recent advances allow TACE treatment of both early stage patients (i.e. those with a solitary nodule or up to 3 nodules under 3 cm) and some advanced stage patients.

Trans-arterial Chemoembolization is the most widely utilized and is considered the first-line treatment recommended for patients staged as intermediate HCC (Barcelona Clinic Liver Cancer stage B). If applied correctly, TACE can produce survival benefits without adversely affecting hepatic functional reserve.

Two TACE techniques have been used since 2004, conventional TACE (c-TACE) and TACE with drug-eluting beads (DEB-TACE). Conventional TACE was evidenced first to treat intermediate stage HCC patients. It combines the trans-catheter delivery of chemotherapy using Lipiodol-based emulsion plus an embolizing agent to achieve strong cytotoxic and ischemic effects. Drug-eluting beads (DEB) were developed in order to slowly release chemotherapeutic agents, and to increase ischemia intensity and duration.

The introduction of TACE with drug eluting beads (DEB-TACE) was primarily developed to enhance the delivery of the chemotherapeutic agent while minimizing systemic toxicity and to provide a standardized embolizing effect. DEBs are embolic microspheres loaded with a chemotherapeutic agent (mostly doxorubicin) with the ability of slow drug release, which should ensure high local and low systemic drug concentrations. Indeed, systemic levels of doxorubicin were significantly lower in patients receiving DEB-TACE compared to patients receiving c-TACE with Lipiodol.

DEB-TACE was introduced 10 years ago with the aim to improve the overall c-TACE outcomes and to diminish the side effects of the procedure. It is based on the use of microspheres that exploit ionic bonds and are able to actively sequester and then slowly release the cytotoxic drug inside the target lesion. Moreover, the use of particles allows a deeper distal embolization of small vessels, ensuring a permanent highly selective occlusion of the tumor-feeding arteries.

DEB-TACE has several advantages over c-TACE, such as the delivery of higher concentrations of chemotherapeutic agents directly to tumors, lower rates of systemic complications, greater efficacy in advanced stage or large tumors, and better standardization of the procedure itself.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Drug Eluting Bead Transarterial Chemoembolization

Group Type ACTIVE_COMPARATOR

Doxorubicin-Eluting Beads

Intervention Type DRUG

* The patients will be categorized in two randomized groups; c-TACE group (A) and DEB-TACE group (B).
* After patient counseling and obtaining a written consent to participate in the study, both groups will be subjected to the interventional procedure according to patient group; Group A; Lipidol-Doxorubicin emulsion material followed by gel foam embolic material will be injected through the catheter directly into tumor feeding vessels through transarterial catheter.

Group B; Doxorubicin-Eluting Beads will be injected through the catheter directly into tumor feeding vessels through transarterial catheter.

conventional Transarterial Chemoembolization

Group Type ACTIVE_COMPARATOR

Doxorubicin-Eluting Beads

Intervention Type DRUG

* The patients will be categorized in two randomized groups; c-TACE group (A) and DEB-TACE group (B).
* After patient counseling and obtaining a written consent to participate in the study, both groups will be subjected to the interventional procedure according to patient group; Group A; Lipidol-Doxorubicin emulsion material followed by gel foam embolic material will be injected through the catheter directly into tumor feeding vessels through transarterial catheter.

Group B; Doxorubicin-Eluting Beads will be injected through the catheter directly into tumor feeding vessels through transarterial catheter.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Doxorubicin-Eluting Beads

* The patients will be categorized in two randomized groups; c-TACE group (A) and DEB-TACE group (B).
* After patient counseling and obtaining a written consent to participate in the study, both groups will be subjected to the interventional procedure according to patient group; Group A; Lipidol-Doxorubicin emulsion material followed by gel foam embolic material will be injected through the catheter directly into tumor feeding vessels through transarterial catheter.

Group B; Doxorubicin-Eluting Beads will be injected through the catheter directly into tumor feeding vessels through transarterial catheter.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lipidol-Doxorubicin emulsion

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \- Child-Pugh A or B cirrhosis.
* ECOG performance status (PS) Grade 2 or below.
* BCLC stage B or C.
* No serious concurrent medical illness.
* Radiologically or histologically proven HCC (an alpha-fetoprotein level \> 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection is considered eligible).
* Unresectable and locally advanced disease without extra-hepatic disease.
* Nodular tumor morphology with measurable lesion on CT with less than 50% involvement of liver by HCC.
* Size of largest tumor is less than or equal to 15cm in largest dimension.
* Number of main tumor is less than or equal to 5, excluding associated small satellite lesions.
* Patent main portal vein.

Exclusion Criteria

* \- Child-Pugh C cirrhosis (evidence of poor liver function).
* History of significant concurrent medical illness such as ischemic heart disease or heart failure.
* Serum creatinine level \> 2 mg/dL.
* Presence of extrahepatic metastasis.
* Predominantly infiltrative lesion.
* Diffuse tumor morphology with extensive lesions involving both lobes.
* Hepatic artery thrombosis.
* Thrombosis of the main portal vein.
* Tumor invasion of portal branch of contralateral lobe.

Eligible Sex

ALL

Accepts Healthy Volunteers

No