Preoperative Transarterial Chemoembolization for Resectable HCC With Portal Venous Invasion

Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus Clinical Trial

Official title:

Efficacy of Preoperative Transarterial Chemoembolization for Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: A Prospective Non-Randomized Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952353
• Other study ID #: HCC-200602
• Status: Completed
• Phase: Phase 4
• Start date: February 2006
• Est. completion date: August 2013

Study information

• Verified date: March 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
• Thrombosis

Intervention

Procedure:
• Preoprative TACE

• Liver resection plus Thrombectomy
Liver resection plus Thrombectomy

Locations

Country	Name	City	State
China	SunYat-sen University cancer center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

Peng ZW, Guo RP, Zhang YJ, Lin XJ, Chen MS, Lau WY. Hepatic resection versus transcatheter arterial chemoembolization for the treatment of hepatocellular carcinoma with portal vein tumor thrombus. Cancer. 2012 Oct 1;118(19):4725-36. doi: 10.1002/cncr.2656 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival time		5years
Secondary	disease free survival		5 years
Secondary	Number of Adverse Events	All severe adverse events for the entire course of treatment, including treatment for primary tumor and recurrent tumor.	30 days

External Links

•   web site of Cancer Center, Sun Yat-sen University