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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: epirubicin and lipiodol Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Eastern Hepatobilliary Surgical Hospital
Study Start Date : January 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2010

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Arms and Interventions
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Arm Intervention/treatment
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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2010 ]

Secondary Outcome Measures :
  1. Time to recurrence [ Time Frame: 2010 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820053


Locations
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China, Shanghai
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai, China, 200438
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
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Study Chair: Shen feng, MD Eastern hepatobilliary surgery hospital
More Information
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Responsible Party: ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospotal, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT00820053    
Other Study ID Numbers: EHBH-RCT-2008-014-2
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016
Keywords provided by ShenFeng, Eastern Hepatobiliary Surgery Hospital:
hepatocellular carcinoma
adjuvant therapy
TACE
time to recurrence
overall survival
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Liver Diseases
Epirubicin
Ethiodized Oil
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action