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

NCT ID: NCT02032368

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-12-31

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.

Conditions

Circulating Tumor Cell; Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

TACE group

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

Group Type: EXPERIMENTAL

transarterial chemoembolization (TACE)

Intervention Type: PROCEDURE

Control group

Patients in Control group receive no management.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

transarterial chemoembolization (TACE)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Interventional Radiology; Cancer Center; Guangdong General Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

CTCtrial001

Identifier Type: -

Identifier Source: org_study_id