Decrease in Circulating Tumour Cell Count Reflects the Effectiveness of Postoperative Adjuvant Transarterial Chemoembolization (TACE) in Preventing Hepatocellular Carcinoma Recurrence

January 8, 2014 updated by: Guangdong Provincial People's Hospital
Circulating tumour cell (CTC) count could reflect the effect of postoperative transarterial chemoembolization (TACE) on hepatocellular carcinoma (HCC) recurrence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Early metastases of hepatocellular carcinoma (HCC) may be detected by the isolation of circulating tumor cells (CTCs) in the bloodstream. During the course of therapeutic attempts, monitoring CTC changes in patients with HCC is helpful for the efficacy assessment. Nevertheless, the markers used for the detection, such as a-feto protein, asialoglycoprotein receptor or epithelial cell adhesion molecule, CD133 or CD90, are not specific for HCC CTCs. In spite of these limitations, a timely determination of the existence of CTCs will be beneficial for the monitoring of distant metastases, the evaluation of therapeutic attempts, and the prediction of prognosis.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

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
        • Department of Interventional Radiology; Cancer Center; Guangdong General Hospital

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • definitive pathological diagnosis of HCC based on World Health Organization (WHO) criteria;
  • underwent curative resection one month ago, CT or MRI detecting no new lesions when recruited;
  • CTC counts≥2 after resection;
  • age between 18 and 75 years;
  • adequate hematologic function (platelet count: >60 × 109 platelets/L; hemoglobin: >90g/L; and prothrombin time: <3 seconds above control);
  • adequate renal function (serum creatinine: ≤1.5 × upper limit of normal);
  • Child-Pugh classification A or B grade

Exclusion Criteria:

  • a hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the nontumorous liver parenchyma on arterial phase computed tomography scans);
  • diffuse-type HCC;
  • evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy;
  • severe underlying cardiac or renal diseases;
  • color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation;
  • obstructive jaundice

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: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TACE group
Patients in TACE group receive transarterial chemoembolization (TACE) one month after resection.
Procedure: transarterial chemoembolization (TACE)
NO_INTERVENTION: Control group
Patients in Control group receive no management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of circulating tumor cell(CTC) count at different timepoints
Time Frame: time before TACE and time after TACE
The time points for blood collection to count CTC were1)one day before TACE(also one month after resection);2)three days after TACE;3)one month after TACE;4) two months after TACE;5)three months after TACE;6)six months after TACE;7) one year after TACE.
time before TACE and time after TACE

Collaborators and Investigators

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

Sponsor

Guangdong Provincial People's Hospital

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

July 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 8, 2014

First Posted (ESTIMATE)

January 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTCtrial001

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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