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

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ClinicalTrials.gov Identifier: NCT02032368
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Guangdong Provincial People's Hospital

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

Condition or disease Intervention/treatment Phase
Circulating Tumor Cell; Hepatocellular Carcinoma Procedure: transarterial chemoembolization (TACE) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Official Title: Decrease in Circulating Tumour Cell Count Reflects the Effectiveness of Postoperative Adjuvant Transarterial Chemoembolization (TACE) in Preventing Hepatocellular Carcinoma Recurrence
Study Start Date : July 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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.



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032368


Locations
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China, Guangdong
Department of Interventional Radiology; Cancer Center; Guangdong General Hospital
Guangzhou, Guangdong, China
Sponsors and Collaborators
Guangdong Provincial People's Hospital

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Responsible Party: Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT02032368    
Other Study ID Numbers: CTCtrial001
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by Guangdong Provincial People's Hospital:
circulating tumour cell;
transarterial chemoembolization;
hepatocellular carcinoma;
recurrence
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplastic Cells, Circulating
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes
Neoplasm Metastasis
Neoplastic Processes
Chlorotrianisene
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents