NCT04967482

Brief Summary

This study is conducted to evaluate the efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) compared with conventional transarterial chemoembolization (cTACE) as the conversion therapy for unresectable large hepatocellular carcinoma (HCC).

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
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

July 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2024

Completed
Last Updated

September 15, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

July 8, 2021

Last Update Submit

September 14, 2022

Conditions

Hepatocellular Carcinoma Non-resectable

Keywords

Hepatocellular carcinomaTransarterial chemoembolizationConversion therapy

Outcome Measures

Primary Outcomes (1)

  • Success rate of conversion to resection

    The proportion of patients with initially unresectable large HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after TACE treatment.

    2 years.

Secondary Outcomes (7)

  • Objective response rate (ORR) of TACE treatment

    2 years.

  • Progression-free survival (PFS)

    3 years.

  • Times of TACE procedure to achieve conversion

    2 years.

  • Time for successful conversion

    2 years.

  • Disease-free survival (TFS) of the patients who undergo resection

    2 years.

  • +2 more secondary outcomes

Study Arms (2)

DEB-TACE

EXPERIMENTAL

DEB-TACE will be performed for the patients who choose DEB-TACE as the primary treatment.

Procedure: Drug-eluting bead transarterial chemoembolization (DEB-TACE)

cTACE

ACTIVE COMPARATOR

cTACE will be performed for the patients who choose cTACE as the primary treatment.

Procedure: Conventional transarterial chemoembolization (cTACE)

Interventions

Drug-eluting bead transarterial chemoembolization (DEB-TACE)PROCEDURE

The patients will receive DEB-TACE if they choose DEB-TACE as the primary treatment. DC Bead loaded with epirubicin (1 vial of DC Bead loaded with 60 mg of epirubicin) is used for chemoembolization. During follow-up, TACE will be repeated on demand based on the evaluation of the follow-up laboratory and imaging examination, and the technique method of each TACE procedure (i.e. DEB-TACE) for the same patient should be consistent.

DEB-TACE
Conventional transarterial chemoembolization (cTACE)PROCEDURE

The patients will receive cTACE if they choose cTACE as the primary treatment. An emulsion of epirubicin in lipiodol wiil be injected into the tumor feeding artery. Afterwards, microspheres or polyvinyl alcohol particles mixed with contrast agent will be administered intraarterially until arterial flow stasis was achieved. Generally, the dose of lipiodol and epirubicin should not exceed 30 mL and 60 mg for each procedure. During follow-up, TACE will be repeated on demand based on the evaluation of the follow-up laboratory and imaging examination, and the technique method of each TACE procedure (i.e. cTACE) for the same patient should be consistent.

cTACE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hepatocellular carcinoma confirmed by histopathology and/or cytology, or diagnosed clinically.
  • The tumor lesion was only localized in one liver lobe.
  • Large HCC with single lesion \> 7 cm, or multiple lesions.
  • unresectable HCC evaluated by the surgeon team.
  • The patient is suitable for TACE treatment, which is evaluated by MDT.
  • At least one measurable intrahepatic target lesion.
  • Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A.
  • ECOG score of performance status ≤ 1 point.
  • Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×109/L, absolute value of neutrophils \>1.5×109/L, hemoglobin ≥85 g/L, total bilirubin ≤30 μmol/L, albumin ≥35 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR\<1.5 or PT/APTT normal range.
  • Patients have the willingness to receive TACE as the conversion therapy for surgical resection.

You may not qualify if:

  • Accompanied with tumor thrombus involving the main portal vein, first-order branch or bilateral branches of portal vein.
  • Accompanied with hepatic vein and vena cava tumor thrombus.
  • The extent of the lesion exceeds one liver lobe or extrahepatic metastasis.
  • Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
  • Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE treatment and surgical hepatectomy.
  • History of other malignancies.
  • Uncontrollable infection.
  • Patients with active hepatitis B must undergo antiviral therapy to control HBV-DNA \<10\^3 IU/mL.
  • HCV patients need to complete the anti-HCV therapy before they are enrolled.
  • History of HIV.
  • Allergic to the drugs involved in the research.
  • Patients with gastrointestinal bleeding within 30 days, or other bleeding\> CTCAE grade 3.
  • History of organ or cells transplantation. Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy, or systemic therapy
  • Those with bleeding tendency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mingyue Cai, Dr.

CONTACT

+86-20-34156205cai020@yeah.net

Kangshun Zhu, Dr.

CONTACT

+86-20-34156205zhksh010@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 19, 2021

Study Start

July 9, 2021

Primary Completion

July 8, 2024

Study Completion

July 8, 2024

Last Updated

September 15, 2022

Record last verified: 2022-07

Locations

CN(1)