NCT05103007

Brief Summary

This is a multicenter, randomized, positive parallel controlled clinical study to evaluate the short-term and long-term efficacy and safety of PVL/PVE combined with DEB-TACE in the treatment of unresectable patients with large or large tumors in the right lobe of the liver.

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
200

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable hepatocellular-carcinoma

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 28, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

3.1 years

First QC Date

October 28, 2021

Last Update Submit

December 13, 2023

Conditions

Hepatocellular Carcinoma

Keywords

Drug-eluting bead transarterial chemoembolization(DEB-TACE)portal vein embolization(PVE)portal vein ligation(PVL)

Outcome Measures

Primary Outcomes (2)

  • the rate of tumor resection after treatment

    Until one month after the last treatment.

  • FLR

    the ratio of FLR proliferation after treatment

    Until one month after the last treatment.

Secondary Outcomes (2)

  • Overall survival (OS)

    After operation, up to 3 years

  • Progression-free survival (PFS)

    1, 3 year

Study Arms (2)

Drug-eluting bead transarterial chemoembolization（DEB-TACE)

ACTIVE COMPARATOR

Percutaneous drug-eluting bead transarterial chemoembolization, followed by conventional transarterial chemoembolization（cTACE) every 2 months. A total of 3 times of chemoembolization will be performed.

Procedure: DEB-TACE

PVL/PVE+DEB-TACE

EXPERIMENTAL

PVL and PVE will be performed randomly assigned according to 1:1 according to the random number table.

Procedure: PVL/PVE+DEB-TACE

Interventions

DEB-TACEPROCEDURE

It is suggested that the tumor feeding artery should be selected for the microcatheter. The mixed volume of pirarubicin 80mg + microsphere 2g is about 2ml, and the mixture of at least 10ml and contrast medium is slowly injected with 5-10min.

Drug-eluting bead transarterial chemoembolization（DEB-TACE)
PVL/PVE+DEB-TACEPROCEDURE

DEB-TACE will be performed after the liver function recovered within 7-10 days. After that, conventional transarterial chemoembolization（cTACE) was performed every 2 months, a total of 2-3 times of chemoembolization.

PVL/PVE+DEB-TACE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically diagnosed as large or giant hepatocellular carcinoma of the right lobe of the liver;
  • Child-Pugh liver function grade A,
  • ECOG PS 0-1
  • If the tumor is resected with R0, the remaining liver volume is insufficient
  • ICG-15R \< 30%
  • No serious organic diseases of heart, lung, brain and other organs;
  • No history of other malignant tumors;
  • The patient's survival time is expected to be more than 3 months.

You may not qualify if:

  • Pregnant and lactating women
  • History of organ transplant
  • Tumor thrombus with portal vein trunk or left branch involved;
  • distant metastasis;
  • Patients with obvious liver cirrhosis (Plt \< 100 × 10 \^ 9 / L at admission or gastroscopy suggested esophageal and gastric varices);
  • Active bleeding caused by various causes;
  • Suffering from severe acute or chronic diseases or infectious diseases;
  • History of hepatectomy or TACE treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, 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

Study Officials

  • Wan-guang Zhang

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wan-guang Zhang, M.D.

CONTACT

+8613886195965wgzhang@tjh.tjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 2, 2021

Study Start

December 1, 2021

Primary Completion

December 31, 2024

Study Completion

June 30, 2025

Last Updated

December 19, 2023

Record last verified: 2023-12

Locations

CN(1)