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

Hepatocellular Carcinoma Clinical Trial

— CCGLC-004  

Official title:

A Multicenter, Randomized, Positive Parallel Controlled Clinical Trial of PVE/PVL Combined With DEB-TACE in the Treatment of Large or Large Liver Cancer in the Right Lobe of the Liver Without Hepatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05103007
• Other study ID #: TJ-IRB20210118
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: Tongji Hospital
• Contact: Wan-guang Zhang, M.D.
• Phone: +8613886195965
• Email: wgzhang[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Neoplasms

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of tumor resection after treatment		Until one month after the last treatment.
Primary	FLR	the ratio of FLR proliferation after treatment	Until one month after the last treatment.
Secondary	Overall survival (OS)	The overall survival time refers to the time from the first interventional therapy to the patient's death or the last follow-up, whichever appears early.	After operation, up to 3 years
Secondary	Progression-free survival (PFS)	Disease progression-free survival time refers to the imaging evaluation of the patient after the first interventional therapy, the tumor does not continue to grow, new, distant metastasis; there is no increase in alpha-fetoprotein	1, 3 year