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

Sponsored by:	Eastern Hepatobiliary Surgery Hospital
Information provided by:	Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:	NCT00820053

Purpose

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	Intervention	Phase
Hepatocellular Carcinoma	Drug: epirubicin and lipiodol	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Epirubicin hydrochloride Epirubicin Lipiodol Ethiodized oil Chlorotrianisene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Eastern Hepatobilliary Surgical Hospital

Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:

Overall survival [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to recurrence [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
no adjuvant TACE: No Intervention 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
adjuvant TACE: Experimental 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction,which may affect the treatment of liver cancer.
Patients with other diseases which may affect the treatment mentioned here.
Patients with 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.
Patients would not sign the consent to the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820053

Locations

China
Eastern hepatobilliary surgery hospital
shanghai, China, 200438

Sponsors and Collaborators

Eastern Hepatobiliary Surgery Hospital

Investigators

Study Chair:

Shen feng, MD

Eastern hepatobilliary surgery hospital

More Information

Responsible Party:	Eastern Hepatobiliary Surgery Hospital ( ShenFeng )
Study ID Numbers:	EHBH-RCT-2008-014-2
Study First Received:	January 7, 2009
Last Updated:	January 10, 2009
ClinicalTrials.gov Identifier:	NCT00820053
Health Authority:	China: Ministry of Health; United States: Institutional Review Board

Keywords provided by Eastern Hepatobiliary Surgery Hospital:

hepatocellular carcinoma
adjuvant therapy
TACE
time to recurrence
overall survival

Study placed in the following topic categories:

Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Epirubicin
Recurrence
Carcinoma

Liver Neoplasms
Digestive System Diseases
Ethiodized Oil
Gastrointestinal Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents

Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009