PVE/PVL Combined With DEB-TACE in the Treatment of Patients With Large and Unresectable Liver Cancer (CCGLC-004)

Tongji Hospital

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: PVL/PVE+DEB-TACE; Procedure: DEB-TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT05103007

TJ-IRB20210118

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Drug-eluting bead transarterial chemoembolization（DEB-TACE)

Active Comparator group

Description:

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.

Treatment:

Procedure: DEB-TACE

PVL/PVE+DEB-TACE

Experimental group

Description:

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

Treatment:

Procedure: PVL/PVE+DEB-TACE