NCT05093920

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

1.9 years

First QC Date

October 13, 2021

Last Update Submit

April 10, 2023

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Tumor size

    Triphasic CT scan of the liver measures the maximum diameter of tumor according to modified RECIST (mRecist) criteria.

    four-six weeks after treatment

Secondary Outcomes (1)

  • Serum Alpha-fetoprotein level ng/ml.

    four-six weeks after treatment

Study Arms (2)

Drug Eluting Bead Transarterial Chemoembolization

ACTIVE COMPARATOR

Drug Eluting Bead Transarterial Chemoembolization

Drug: Doxorubicin-Eluting Beads

conventional Transarterial Chemoembolization

ACTIVE COMPARATOR

conventional Transarterial Chemoembolization

Drug: Doxorubicin-Eluting Beads

Interventions

Doxorubicin-Eluting BeadsDRUG

* 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.

Also known as: Lipidol-Doxorubicin emulsion
Drug Eluting Bead Transarterial Chemoembolizationconventional Transarterial Chemoembolization

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, 88525, Egypt

Location

Related Publications (4)

  • Cho SM, Chu HH, Kim JW, Kim JH, Gwon DI. Initial Transarterial Chemoembolization (TACE) Using HepaSpheres 20-40 microm and Subsequent Lipiodol TACE in Patients with Hepatocellular Carcinoma > 5 cm. Life (Basel). 2021 Apr 18;11(4):358. doi: 10.3390/life11040358.

    PMID: 33919658BACKGROUND

  • Gholam PM, Iyer R, Johnson MS. Multidisciplinary Management of Patients with Unresectable Hepatocellular Carcinoma: A Critical Appraisal of Current Evidence. Cancers (Basel). 2019 Jun 22;11(6):873. doi: 10.3390/cancers11060873.

    PMID: 31234476BACKGROUND

  • Li H, Wu F, Duan M, Zhang G. Drug-eluting bead transarterial chemoembolization (TACE) vs conventional TACE in treating hepatocellular carcinoma patients with multiple conventional TACE treatments history: A comparison of efficacy and safety. Medicine (Baltimore). 2019 May;98(21):e15314. doi: 10.1097/MD.0000000000015314.

    PMID: 31124925BACKGROUND

  • Melchiorre F, Patella F, Pescatori L, Pesapane F, Fumarola E, Biondetti P, Brambillasca P, Monaco C, Ierardi AM, Franceschelli G, Carrafiello G. DEB-TACE: a standard review. Future Oncol. 2018 Dec;14(28):2969-2984. doi: 10.2217/fon-2018-0136. Epub 2018 Jul 10.

    PMID: 29987957BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Ahmed E Mohamed, Master

    Sohag University

    PRINCIPAL INVESTIGATOR

  • Mohamed Z Ali, MD

    Sohag University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer at department of diagnostic and interventional radiology

Study Record Dates

First Submitted

October 13, 2021

First Posted

October 26, 2021

Study Start

January 1, 2022

Primary Completion

December 1, 2023

Study Completion

January 30, 2024

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)