Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-29 @ 11:21 AM
Study NCT ID:
NCT00820157
Status:
COMPLETED
Last Update Posted:
2013-08-13
First Post:
2009-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cytoreductive Surgery and Transarterial Chemoembolization (TACE) Versus TACE for Hepatocellular Carcinoma
Sponsor:
Eastern Hepatobiliary Surgery Hospital
Organization:
Study Overview
Official Title:
A Prospective Randomized Trial Comparing Cytoreductive Surgery Followed by Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone for Multinodular Hepatocellular Carcinoma (MNHCC)
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TACE
Brief Summary:
The aim of this study is to compare the surgical outcomes of cytoreductive surgery followed by Transarterial Chemoembolization (TACE) with TACE alone in patients with MNHCC so as to establish a treatment standard for MNHCC.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: