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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: DEB-TACE
* Procedure: PVL/PVE+DEB-TACE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug-eluting bead transarterial chemoembolization（DEB-TACE)<br>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<br>* 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.<br>|
| Experimental: PVL/PVE+DEB-TACE<br>PVL and PVE will be performed randomly assigned according to 1:1 according to the random number table. | Procedure: PVL/PVE+DEB-TACE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-eluting bead transarterial chemoembolization(DEB-TACE), portal vein embolization(PVE), portal vein ligation(PVL)