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

NCT02032368 | Completed DMC

• 1 other identifier: CTCtrial001
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Circulating Tumor Cell;; Hepatocellular Carcinoma

Keywords

circulating tumour cell;; transarterial chemoembolization;; hepatocellular carcinoma;; recurrence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

TACE group

EXPERIMENTAL

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

Procedure: transarterial chemoembolization (TACE)

Control group

NO INTERVENTION

Patients in Control group receive no management.

Interventions

transarterial chemoembolization (TACE) PROCEDURE

TACE group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Department of Interventional Radiology; Cancer Center; Guangdong General Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Neoplastic Cells, Circulating; Carcinoma, Hepatocellular; Recurrence

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 10, 2014
• Study Start: July 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

CN (1)