Clinical trial NCT02032368: 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
Overall status: COMPLETED
Phase: NA
Conditions: Circulating Tumor Cell;
Hepatocellular Carcinoma
Keywords: circulating tumour cell;
transarterial chemoembolization;
hepatocellular carcinoma;
recurrence
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Change of circulating tumor cell(CTC) count at different timepoints
timeFrame: time before TACE and time after TACE
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Interventional Radiology; Cancer Center; Guangdong General Hospital
state: Guangdong
Study officials:
References: