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
|Condition or disease||Intervention/treatment||Phase|
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Cytoreductive Surgery
Cytoreductive Surgery followed by TACE
Procedure: Cytoreductive Surgery
Cytoreductive Surgery followed by TACE for MNHCC
Other Name: Cytoreductive group
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 ]
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
|Eastern Hepatobiliary Surgery Hospital|
|Shanghai, Shanghai, China, 200438|
|Study Chair:||Weiping Zhou, M.D.||Eastern Hepatobiliary Surgery Hospital, Second Military Medical University|