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A Trial of Adjuvant Transarterial Chemoembolization (TACE) for Preventing Tumor Recurrence After Liver Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00820053
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital

Tracking Information
First Submitted Date  ICMJE January 7, 2009
First Posted Date  ICMJE January 9, 2009
Last Update Posted Date April 1, 2016
Study Start Date  ICMJE January 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2009)
Overall survival [ Time Frame: 2010 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2009)
Time to recurrence [ Time Frame: 2010 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Adjuvant Transarterial Chemoembolization (TACE) for Preventing Tumor Recurrence After Liver Resection
Official Title  ICMJE Eastern Hepatobilliary Surgical Hospital
Brief Summary The aim of this study is to analyze the therapeutic effect of adjuvant TACE after resection.Patients receiving curative resection (R0) were randomized to postoperative TACE group and no TACE group. The time to recurrence ,the overall survival as well as the incidence of complications after therapy was observed to confirm the role of adjuvant TACE.
Detailed Description

Although resection of hepatocellular carcinoma is potentially curative, local recurrence is common with the recurrence rate higher than 50% during 5 years. So to reduce the recurrence rate of HCC, some interventions had been tried in clinic, including transarterial chemoembolization (TACE), immunotherapy, and interferon treatment etc. But few of these adjuvant therapies had been proved effective and their long term efficacy and clinical application remained further explored.

TACE had been prove to be effective in patients with advanced stage of HCC in randomized controlled trials and meta-analysis, but the role of adjuvant TACE after liver resection is controversial. The results getting from different randomized control trials varied significantly because of the bias of patient selection, different study design,the small size of sample, different drug used in chemotherapy and lack of proper stratification…,so a big sample size, well patients selected and well designed randomized controlled trial is needed to further confirm the role of the postoperative TACE.

Patients with HCC who received curative liver resection (R0) were randomly assigned 1:1 by the doctors to receive no adjuvant TACE(control group) or TACE(treatment group). All patients in the treatment group received adjuvant TACE 45 days after liver resection. The outcomes of patients were evaluated during the 3-years follow up.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE Drug: epirubicin and lipiodol
using the technology of Seldinger,The drugs (30 mg epirubicin mixed with 5 ml lipiodol) are given via hepatica propria artery.
Other Name: transarterial chemoembolization
Study Arms  ICMJE
  • No Intervention: no adjuvant TACE
    controll group with patients who don't receive any adjuvant therapy after liver resection, to compare with the treatment group with patients who receive adjuvant TACE after liver resection
  • Experimental: adjuvant TACE
    patients who adjuvant TACE after liver resection
    Intervention: Drug: epirubicin and lipiodol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2009)
450
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female patients > 18 years and <=70 years of age.
  2. Patients with HCC who received curative liver resection (R0).
  3. 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.
  4. 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 .
  5. Karnofsky Performance Score performance over 60 .
  6. Patients who can understand this trial and have signed information consent

Exclusion Criteria:

  1. Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction,which may affect the treatment of liver cancer.
  2. Patients with other diseases which may affect the treatment mentioned here.
  3. Patients with medical history of other malignant tumors.
  4. Subjects participating in other clinical trials.
  5. Extrahepatic metastasis, portal vein or other major vascular involvement. liver function:Child C.
  6. Patients would not sign the consent to the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00820053
Other Study ID Numbers  ICMJE EHBH-RCT-2008-014-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ShenFeng, Eastern Hepatobiliary Surgery Hospital
Study Sponsor  ICMJE Eastern Hepatobiliary Surgery Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Shen feng, MD Eastern hepatobilliary surgery hospital
PRS Account Eastern Hepatobiliary Surgery Hospital
Verification Date March 2016

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