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

NCT ID: NCT00820157

Last Updated: 2013-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2012-12-31

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.

Conditions

Hepatocellular Carcinoma

Keywords

Carcinoma, Hepatocellular; Chemoembolization, Therapeutic; Cytoreductive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cytoreductive Surgery

Cytoreductive Surgery followed by TACE

Group Type: ACTIVE_COMPARATOR

Cytoreductive Surgery

Intervention Type: PROCEDURE

Cytoreductive Surgery followed by TACE for MNHCC

TACE

TACE alone

Group Type: EXPERIMENTAL

TACE

Intervention Type: PROCEDURE

TACE alone or TACE followed by downstage resection for MNHCC

Interventions

Cytoreductive Surgery

Cytoreductive Surgery followed by TACE for MNHCC

Intervention Type: PROCEDURE

TACE

TACE alone or TACE followed by downstage resection for MNHCC

Intervention Type: PROCEDURE

Other Intervention Names

Cytoreductive group; TACE group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role: lead

Responsible Party

ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weiping Zhou, M.D.

Role: STUDY_CHAIR

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Locations

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

EHBH-RCT-2008-021

Identifier Type: -

Identifier Source: org_study_id