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Completed

NCT Number: NCT01952353

Preoperative Transarterial Chemoembolization for Resectable HCC With Portal Venous Invasion

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SunYat-sen University cancer center

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoprative TACE

Procedure

Other names: Preoperative transarterial chemoembolization

Liver resection plus Thrombectomy

Procedure

Liver resection plus Thrombectomy

Other names: Removal of all tumor tissue by surgery

Primary outcomes

  1. overall survival time

    Time frame: 5years

Secondary outcomes

  1. disease free survival

    Time frame: 5 years

  2. Number of Adverse Events

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Sep 27, 2013
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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