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

Not Applicable

Completed

• Conditions: Circulating Tumor Cell; Hepatocellular Carcinoma
• Interventions: Procedure: transarterial chemoembolization (TACE)

• Registration Number: NCT02032368
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-01
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-08
• Last Update Submitted: 2014-01-08
• Study First Posted: 2014-01-10
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACE group	transarterial chemoembolization (TACE)	Patients in TACE group receive transarterial chemoembolization (TACE) one month after resection.

Primary Outcome Measures

Name	Time	Method
Change of circulating tumor cell(CTC) count at different timepoints	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.

Trial Locations

Locations (1)

Department of Interventional Radiology; Cancer Center; Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China