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

Primary Purpose

Circulating Tumor Cell;, Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transarterial chemoembolization (TACE)
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Circulating Tumor Cell; focused on measuring circulating tumour cell;, transarterial chemoembolization;, hepatocellular carcinoma;, recurrence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TACE group

Control group

Arm Description

Patients in TACE group receive transarterial chemoembolization (TACE) one month after resection.

Patients in Control group receive no management.

Outcomes

Primary Outcome Measures

Change of circulating tumor cell(CTC) count at different timepoints
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.

Secondary Outcome Measures

Full Information

First Posted
January 6, 2014
Last Updated
January 8, 2014
Sponsor
Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02032368
Brief Title
Decrease in Circulating Tumour Cell Count Reflects the Effectiveness of Postoperative Adjuvant Transarterial Chemoembolization (TACE) in Preventing Hepatocellular Carcinoma Recurrence
Official Title
Decrease in Circulating Tumour Cell Count Reflects the Effectiveness of Postoperative Adjuvant Transarterial Chemoembolization (TACE) in Preventing Hepatocellular Carcinoma Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Circulating tumour cell (CTC) count could reflect the effect of postoperative transarterial chemoembolization (TACE) on hepatocellular carcinoma (HCC) recurrence.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circulating Tumor Cell;, Hepatocellular Carcinoma
Keywords
circulating tumour cell;, transarterial chemoembolization;, hepatocellular carcinoma;, recurrence

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TACE group
Arm Type
Experimental
Arm Description
Patients in TACE group receive transarterial chemoembolization (TACE) one month after resection.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in Control group receive no management.
Intervention Type
Procedure
Intervention Name(s)
transarterial chemoembolization (TACE)
Primary Outcome Measure Information:
Title
Change of circulating tumor cell(CTC) count at different timepoints
Description
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 Frame
time before TACE and time after TACE

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Interventional Radiology; Cancer Center; Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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