Cytoreductive Surgery and Transarterial Chemoembolization (TACE) Versus TACE for Hepatocellular Carcinoma (TACE)

• ClinicalTrials.gov Identifier: NCT00820157
• Recruitment Status: Completed
• First Posted: January 12, 2009
• Last Update Posted: August 13, 2013
• Sponsor: Eastern Hepatobiliary Surgery Hospital
• Information provided by (Responsible Party): ShenFeng, Eastern Hepatobiliary Surgery Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hepatocellular Carcinoma	Procedure: Cytoreductive Surgery; Procedure: TACE	Not Applicable

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.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Cytoreductive Surgery; Cytoreductive Surgery followed by TACE	Procedure: Cytoreductive Surgery; Cytoreductive Surgery followed by TACE for MNHCC; Other Name: Cytoreductive group
Experimental: TACE; TACE alone	Procedure: TACE; TACE alone or TACE followed by downstage resection for MNHCC; Other Name: TACE group

Outcome Measures

Primary Outcome Measures :

1. the overall survival rate of each group [ Time Frame: 3 years ]

Secondary Outcome Measures :

1. the disease-free survival rate of each group [ Time Frame: 3 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

China, Shanghai

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai, China, 200438

Sponsors and Collaborators

Eastern Hepatobiliary Surgery Hospital

Investigators

• Study Chair: Weiping Zhou, M.D.; Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

More Information

• 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
• Last Update Posted: August 13, 2013
• Last Verified: August 2013

Keywords provided by ShenFeng, Eastern Hepatobiliary Surgery Hospital:

Carcinoma, Hepatocellular; Chemoembolization, Therapeutic; Cytoreductive

Additional relevant MeSH terms:

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