Cytoreductive Surgery and Transarterial Chemoembolization (TACE) Versus TACE for Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT00820157
First received: January 8, 2009
Last updated: August 10, 2013
Last verified: August 2013

January 8, 2009
August 10, 2013
November 2008
November 2010   (final data collection date for primary outcome measure)
the overall survival rate of each group [ Time Frame: 3 years ] [ Designated as safety issue: No ]
overall survival [ Time Frame: 1,2 and 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00820157 on ClinicalTrials.gov Archive Site
the disease-free survival rate of each group [ Time Frame: 3 years ] [ Designated as safety issue: No ]
disease-free survival, morbidity of treatment [ Time Frame: 1,2 and 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cytoreductive Surgery and Transarterial Chemoembolization (TACE) Versus TACE for Hepatocellular Carcinoma
A Prospective Randomized Trial Comparing Cytoreductive Surgery Followed by Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone for Multinodular Hepatocellular Carcinoma (MNHCC)

The aim of this study is to compare the surgical outcomes of cytoreductive surgery followed by Transarterial Chemoembolization (TACE) with TACE alone in patients with MNHCC so as to establish a treatment standard for MNHCC.

Hepatocellular carcinoma (HCC) is one of the world's most common malignancies, especially in East-Asian countries. Hepatic resection has been accepted as the only means of cure for patients with HCC. The results of hepatic resection for early-stage HCC are favorable.Nevertheless, the role of surgical resection for multinodular HCC (MNHCC) is less well-defined.The presence of multiple tumors has been shown to be one of the most significant independent factors to influence cumulative survival rates in HCC after hepatic resection.Using the BCLC criteria,liver transplantation provides an alternative curative treatment option for MNHCC with size ≤ 5 cm in diameter and tumor number <3,but MNHCC beyond these criteria usually receive palliative therapy.

For MNHCC which not suitable for curative treatment, non-surgical and surgical interventions are available for palliative care.Cytoreductive surgery has the potential to increase the quality and quantity of survival in patients with advanced HCC. Cytoreductive surgery is carried out with partial hepatectomy,cryosurgery,microwave coagulation therapy(MCT),or absolute alcohol injection.It has been shown to prolong survival and provide good symptomatic relief in patients with good surgical risks in non-randomized studies.Cytoreductive surgery aims at removal or destruction of all macroscopic tumours, allowing microscopic foci to persist while preserving as much of the functional liver tissue as possible. The development of effective local ablative therapy (LAT), such as radiofrequency ablation (RFA) therapy, facilitates reduction of the tumour burden even further during the operation.Cytoreductive surgery can also be followed by other non-surgical treatments,such as regional therapy or systemic therapy, to deal with the residual disease or micrometastases.

The aim of this study is to compare the surgical outcomes of cytoreductive surgery followed by TACE with TACE alone in patients with MNHCC so as to establish a treatment standard for MNHCC.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • Procedure: Cytoreductive Surgery
    Cytoreductive Surgery followed by TACE for MNHCC
    Other Name: Cytoreductive group
  • Procedure: TACE
    TACE alone or TACE followed by downstage resection for MNHCC
    Other Name: TACE group
  • Active Comparator: Cytoreductive Surgery
    Cytoreductive Surgery followed by TACE
    Intervention: Procedure: Cytoreductive Surgery
  • Experimental: TACE
    TACE alone
    Intervention: Procedure: TACE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2012
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patients > 18 years and <=70 years of age.
  • at least 2 radiologic imaging showing characteristic features of HCC or one radiologic imaging associated with AFP >400 or cytologic/histologic evidence.
  • tumor number >3 and <=5,maximum diameter >5cm and <=15cm;without evidence of radiologically definable vascular invasion or extrahepatic metastasis.
  • Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
  • No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
  • Hb ≥90g/L,WBC ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³
  • Patients who can understand this trial and have signed information consent

Exclusion Criteria:

  • Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
  • Patients with other diseases which may affect the treatment mentioned.
  • Patients with a medical history of other malignant tumors.
  • Subjects participating in other clinical trials.
  • Extrahepatic metastasis, portal vein or other major vascular involvement.
  • liver function:Child C.
  • no pathological evidence of HCC.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00820157
EHBH-RCT-2008-021
Yes
ShenFeng, Eastern Hepatobiliary Surgery Hospital
Eastern Hepatobiliary Surgery Hospital
Not Provided
Study Chair: Weiping Zhou, M.D. Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Eastern Hepatobiliary Surgery Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP