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

G

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status

Completed

Conditions

Hepatocellular Carcinoma
Circulating Tumor Cell;

Treatments

Procedure: transarterial chemoembolization (TACE)

Study type

Interventional

Funder types

Other

Identifiers

NCT02032368
CTCtrial001

Details and patient eligibility

About

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

Full 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.

Enrollment

57 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

57 participants in 2 patient groups

TACE group
Experimental group
Description:
Patients in TACE group receive transarterial chemoembolization (TACE) one month after resection.
Treatment:
Procedure: transarterial chemoembolization (TACE)
Control group
No Intervention group
Description:
Patients in Control group receive no management.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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