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

NCT00820157 | Completed DMC

• 1 other identifier: EHBH-RCT-2008-021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Keywords

Carcinoma, Hepatocellular; Chemoembolization, Therapeutic; Cytoreductive

Outcome Measures

Primary Outcomes (1)

• the overall survival rate of each group

  3 years

Secondary Outcomes (1)

• the disease-free survival rate of each group

  3 years

Study Arms (2)

Cytoreductive Surgery

ACTIVE COMPARATOR

Cytoreductive Surgery followed by TACE

Procedure: Cytoreductive Surgery

TACE

EXPERIMENTAL

TACE alone

Procedure: TACE

Interventions

Cytoreductive Surgery PROCEDURE

Cytoreductive Surgery followed by TACE for MNHCC

Also known as: Cytoreductive group

Cytoreductive Surgery

TACE PROCEDURE

TACE alone or TACE followed by downstage resection for MNHCC

Also known as: TACE group

TACE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Cytoreduction Surgical Procedures

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Weiping Zhou, M.D.

  Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of the Eastern Hepatobiliary Surgery Hospital

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 12, 2009
• Study Start: November 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2012
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

CN (1)