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OpenTrials
Completed

NCT Number: NCT02032368

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Transarterial chemoembolization (TACE)

Procedure

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 10, 2014
Registry last updated
Jan 10, 2014

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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