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
  Purpose

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.


Condition Intervention
Hepatocellular Carcinoma
Procedure: Cytoreductive Surgery
Procedure: TACE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial Comparing Cytoreductive Surgery Followed by Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone for Multinodular Hepatocellular Carcinoma (MNHCC)

Resource links provided by NLM:


Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:
  • the overall survival rate of each group [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the disease-free survival rate of each group [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: November 2008
Study Completion Date: December 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cytoreductive Surgery
Cytoreductive Surgery followed by TACE
Procedure: Cytoreductive Surgery
Cytoreductive Surgery followed by TACE for MNHCC
Other Name: Cytoreductive group
Experimental: TACE
TACE alone
Procedure: TACE
TACE alone or TACE followed by downstage resection for MNHCC
Other Name: TACE group

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820157

Locations
China, Shanghai
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai, China, 200438
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
Study Chair: Weiping Zhou, M.D. Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
  More Information

No publications provided

Responsible Party: ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT00820157     History of Changes
Other Study ID Numbers: EHBH-RCT-2008-021
Study First Received: January 8, 2009
Last Updated: August 10, 2013
Health Authority: China: Ministry of Health

Keywords provided by Eastern Hepatobiliary Surgery Hospital:
Carcinoma, Hepatocellular
Chemoembolization, Therapeutic
Cytoreductive

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 19, 2014