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

Arm | Intervention/treatment |
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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
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Experimental: adjuvant TACE
patients who adjuvant TACE after liver resection
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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 |
- Overall survival [ Time Frame: 2010 ]
- Time to recurrence [ Time Frame: 2010 ]

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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 |
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.

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
China, Shanghai | |
Eastern hepatobilliary surgery hospital | |
Shanghai, Shanghai, China, 200438 |
Study Chair: | Shen feng, MD | Eastern hepatobilliary surgery hospital |
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 |
hepatocellular carcinoma adjuvant therapy TACE time to recurrence overall survival |
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 |