Cytoreductive Surgery and Transarterial Chemoembolization (TACE) Versus TACE for Hepatocellular Carcinoma (TACE)
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ClinicalTrials.gov Identifier: NCT00820157 |
Recruitment Status :
Completed
First Posted : January 12, 2009
Last Update Posted : August 13, 2013
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Condition or disease | Intervention/treatment | Phase |
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Hepatocellular Carcinoma | Procedure: Cytoreductive Surgery Procedure: TACE | Not Applicable |
Hepatocellular carcinoma (HCC) is one of the world's most common malignancies, especially in East-Asian countries. Hepatic resection has been accepted as the only means of cure for patients with HCC. The results of hepatic resection for early-stage HCC are favorable.Nevertheless, the role of surgical resection for multinodular HCC (MNHCC) is less well-defined.The presence of multiple tumors has been shown to be one of the most significant independent factors to influence cumulative survival rates in HCC after hepatic resection.Using the BCLC criteria,liver transplantation provides an alternative curative treatment option for MNHCC with size ≤ 5 cm in diameter and tumor number <3,but MNHCC beyond these criteria usually receive palliative therapy.
For MNHCC which not suitable for curative treatment, non-surgical and surgical interventions are available for palliative care.Cytoreductive surgery has the potential to increase the quality and quantity of survival in patients with advanced HCC. Cytoreductive surgery is carried out with partial hepatectomy,cryosurgery,microwave coagulation therapy(MCT),or absolute alcohol injection.It has been shown to prolong survival and provide good symptomatic relief in patients with good surgical risks in non-randomized studies.Cytoreductive surgery aims at removal or destruction of all macroscopic tumours, allowing microscopic foci to persist while preserving as much of the functional liver tissue as possible. The development of effective local ablative therapy (LAT), such as radiofrequency ablation (RFA) therapy, facilitates reduction of the tumour burden even further during the operation.Cytoreductive surgery can also be followed by other non-surgical treatments,such as regional therapy or systemic therapy, to deal with the residual disease or micrometastases.
The aim of this study is to compare the surgical outcomes of cytoreductive surgery followed by TACE with TACE alone in patients with MNHCC so as to establish a treatment standard for MNHCC.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective Randomized Trial Comparing Cytoreductive Surgery Followed by Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone for Multinodular Hepatocellular Carcinoma (MNHCC) |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | December 2012 |
Arm | Intervention/treatment |
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Active Comparator: Cytoreductive Surgery
Cytoreductive Surgery followed by TACE
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Procedure: Cytoreductive Surgery
Cytoreductive Surgery followed by TACE for MNHCC
Other Name: Cytoreductive group |
Experimental: TACE
TACE alone
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Procedure: TACE
TACE alone or TACE followed by downstage resection for MNHCC
Other Name: TACE group |
- the overall survival rate of each group [ Time Frame: 3 years ]
- the disease-free survival rate of each group [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

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): NCT00820157
China, Shanghai | |
Eastern Hepatobiliary Surgery Hospital | |
Shanghai, Shanghai, China, 200438 |
Study Chair: | Weiping Zhou, M.D. | Eastern Hepatobiliary Surgery Hospital, Second Military Medical University |
Responsible Party: | ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery Hospital |
ClinicalTrials.gov Identifier: | NCT00820157 |
Other Study ID Numbers: |
EHBH-RCT-2008-021 |
First Posted: | January 12, 2009 Key Record Dates |
Last Update Posted: | August 13, 2013 |
Last Verified: | August 2013 |
Carcinoma, Hepatocellular Chemoembolization, Therapeutic Cytoreductive |
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |