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

NCT ID: NCT05103007

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-06-30

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.

Detailed 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.

Conditions

Hepatocellular Carcinoma

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug-eluting bead transarterial chemoembolization（DEB-TACE)

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.

Group Type: ACTIVE_COMPARATOR

DEB-TACE

Intervention Type: PROCEDURE

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.

PVL/PVE+DEB-TACE

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

Group Type: EXPERIMENTAL

PVL/PVE+DEB-TACE

Intervention Type: PROCEDURE

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.

Interventions

DEB-TACE

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.

Intervention Type: PROCEDURE

PVL/PVE+DEB-TACE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wan-Guang Zhang

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wan-guang Zhang

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wan-guang Zhang, M.D.

Role: CONTACT

Phone: +8613886195965

Email: wgzhang@tjh.tjmu.edu.cn

Facility Contacts

Wan-guang Zhang, M.D.

Role: primary

Other Identifiers

TJ-IRB20210118

Identifier Type: -

Identifier Source: org_study_id