PVE/PVL Combined With DEB-TACE in the Treatment of Patients With Large and Unresectable Liver Cancer

Last updated: December 13, 2023
Sponsor: Tongji Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Cancer

Digestive System Neoplasms

Carcinoma

Treatment

DEB-TACE

PVL/PVE+DEB-TACE

Clinical Study ID

NCT05103007
TJ-IRB20210118
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinically diagnosed as large or giant hepatocellular carcinoma of the right lobe ofthe 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.

Exclusion

Exclusion Criteria:

  • 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 orgastroscopy 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.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: DEB-TACE
Phase:
Study Start date:
December 01, 2021
Estimated Completion Date:
June 30, 2025

Study Description

Most guidelines recommend transarterial chemoembolization (TACE) as the standard of treatment for hepatocellular carcinoma（HCC）which is limited to the right half of the liver, single large or multiple, with / without tumor thrombus of the right branch of the portal vein.While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma. Portal vein embolization(PVE)/portal vein ligation(PVL) is the main means to increase the future liver remnant (FLR), which can reduce the complications after hepatectomy. TACE on the basis of PVE/PVL can not only increase FLR, but also can effectively control the progression of tumor by sequential TACE. This study intends to conduct a multicenter, randomized, positive parallel-controlled clinical study to objectively and scientifically evaluate the short-term and long-term efficacy and safety of ligation of the right portal vein combined with Drug-eluting bead transarterial chemoembolization(DEB-TACE) technique in the treatment of patients with large or large tumors of the right lobe who cannot be resected in I-stage.

Connect with a study center

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

    Wuhan, Hubei 430030
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.