Preoperative Transarterial Chemoembolization for Resectable HCC With Portal Venous Invasion

March 5, 2019 updated by: Shi Ming, Sun Yat-sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • SunYat-Sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperation TACE arm
In the preoperative TACE arm (Arm 2), patients underwent TACE followed by surgical resection. Preoperative TACE sessions were repeated once at 4-week intervals unless patients showed either PD or PVTT PD. Then, the patients were prepared for surgical resection, with the exception of those with unresectable disease after TACE For patients who had unresectable disease after TACE, plans for surgical resection were abandoned and the subsequent treatment course was determined by his/her attending oncologist
Procedure: Liver resection plus Thrombectomy
Liver resection plus Thrombectomy
Other Names:
  • Removal of all tumor tissue by surgery
Procedure: Preoprative TACE
Other Names:
  • Preoperative transarterial chemoembolization
Active Comparator: Resection arm
Liver resection Plus Thrombectomy
Procedure: Liver resection plus Thrombectomy
Liver resection plus Thrombectomy
Other Names:
  • Removal of all tumor tissue by surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival time
Time Frame: 5years
5years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease free survival
Time Frame: 5 years
5 years
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

September 27, 2013

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC-200602

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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