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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032368
• Other study ID #: CTCtrial001
• Status: Completed
• Phase: N/A
• First received: January 6, 2014
• Last updated: January 8, 2014
• Start date: July 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: Guangdong General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Circulating Tumor Cell;
• Hepatocellular Carcinoma
• Neoplastic Cells, Circulating
• Recurrence

Intervention

Procedure:
• transarterial chemoembolization (TACE)

Locations

Country	Name	City	State
China	Department of Interventional Radiology; Cancer Center; Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	time before TACE and time after TACE	Yes