Preoperative Transarterial Chemoembolization for Resectable HCC With Portal Venous Invasion

Phase 4CompletedNCT01952353

Sun Yat-sen University330 enrolled

Overview

Whether preoperative transarterial chemoembolization can prolong survival for the resectable hepatocellular carcinoma remains controversial, particularly in patients with portal vein tumor thrombi. This study designs to systematically identify and summarize the effect of preoperative TACE for resectable HCC with portal venous invasion.

With various improvements in interventional radiology, since the 2005 practice guidelines issued by the American Association for the Study of Liver Diseases , transcatheter arterial chemoembolization has become one of the available locoregional therapies for HCC. Transcatheter arterial chemoembolization, which generally performed in intermediate-stage HCC patients, involves injection of an embolizing agent into the hepatic artery to deprive the tumor of its major nutrient source via embolization of the nutrient artery, resulting in ischemic necrosis of the tumor. To prevent intrahepatic recurrence due to portal vein invasion of the HCC tumor, therapeutic strategies such as preoperative TACE, and postoperative adjuvant chemotherapy have been tried. According to the latest and the most powerful evidence, however, preoperative TACE is not routinely recommended for patients undergoing hepatectomy to treat resectable HCC , and TACE may delay surgical treatment or decrease the resection volume of the liver, or it also may create a missed opportunity for surgical treatment. Rather than subject all these patients to such an invasive procedure and put them at risk for missing opportunity for surgical treatment, it may be better to select optimal candidates to receive surgical resection. Recent studies have even shown favorable long-term survival outcomes of HR in well-selected cases of HCC with PVTT. About whether preoperative transarterial chemoembolization is available for the resectable hepatocellular carcinoma with portal vein tumor thrombi, so far, has hardly been reported.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

330

Conditions

Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Interventions

Preoprative TACEPROCEDURE

Liver resection plus ThrombectomyPROCEDURE

Liver resection plus Thrombectomy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * a) age between 18 and 75 years, * b) HCC with no previous treatment, * c) the presence of major PVTT or less on imaging, * d) Eastern Co-operative Group performance status 030 , * e) resectable disease Exclusion Criteria: * a) Child-Pugh class B or C liver cirrhosis, or evidence of hepatic decompensation including ascites, esophageal or gastric variceal bleeding or hepatic encephalopathy, or ICGR-15 \>15%, * b) an American Society of Anesthesiologists (ASA) score ≥ 3, * c) the presence of distant metastasis or other malignant diseases

Locations (1)

SunYat-sen University cancer center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

overall survival time

Time frame: 5years

Secondary Outcomes

disease free survival

Time frame: 5 years

Number of Adverse Events

All severe adverse events for the entire course of treatment, including treatment for primary tumor and recurrent tumor.

Time frame: 30 days

Data from ClinicalTrials.gov

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