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Sponsored by: |
Eastern Hepatobiliary Surgery Hospital |
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Information provided by: | Eastern Hepatobiliary Surgery Hospital |
ClinicalTrials.gov Identifier: | NCT00820157 |
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.
Condition | Intervention |
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Hepatocellular Carcinoma |
Procedure: Cytoreductive Surgery Procedure: TACE |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Prospective Randomized Trial Comparing Cytoreductive Surgery Followed by Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone for Multinodular Hepatocellular Carcinoma (MNHCC) |
Estimated Enrollment: | 120 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cytoreductive Surgery: Active Comparator
Cytoreductive Surgery followed by TACE
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Procedure: Cytoreductive Surgery
Cytoreductive Surgery followed by TACE for MNHCC
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TACE: Experimental
TACE alone
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Procedure: TACE
TACE alone or TACE followed by downstage resection for MNHCC
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: weiping zhou, M.D. | 0086-21-25070792 | ehphwp@126.com |
Contact: Lei Yin, M.D. | 0086-21-25075492 | yinlei409@hotmail.com |
China | |
Eastern Hepatobiliary Surgery Hospital | Recruiting |
Shanghai, China, 200438 | |
Contact: Weiping Zhou, M.D. 0086-021-25070792 ehphwp@126.com | |
Contact: Lei Yin, M.D. 0086-021-25075492 yinlei409@hotmail.com | |
Principal Investigator: Weiping Zhou, M.D. |
Study Chair: | Weiping Zhou, M.D. | Eastern Hepatobiliary Surgery Hospital, Second Military Medical University |
Responsible Party: | Eastern Hepatobiliary Surgery Hospital ( weiping,zhou ) |
Study ID Numbers: | EHBH-RCT-2008-021 |
Study First Received: | January 8, 2009 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00820157 History of Changes |
Health Authority: | China: Ministry of Health |
Carcinoma, Hepatocellular Chemoembolization, Therapeutic Cytoreductive |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular |
Gastrointestinal Neoplasms Hepatocellular Carcinoma Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Liver Neoplasms Liver Diseases Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Neoplasms by Histologic Type Carcinoma, Hepatocellular Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |