A Prospective Randomized Trial Comparing Cytoreductive Surgery Followed by Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone for Multinodular Hepatocellular Carcinoma (MNHCC)
18 Years
70 Years
Both
Hepatocellular Carcinoma
Trial Information
A Prospective Randomized Trial Comparing Cytoreductive Surgery Followed by Transcatheter Arterial Chemoembolization (TACE) Versus TACE Alone for Multinodular Hepatocellular Carcinoma (MNHCC)
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
the overall survival rate of each group
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Weiping Zhou, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Authority:
China: Ministry of Health
Study ID:
EHBH-RCT-2008-021
NCT ID:
NCT00820157
Start Date:
November 2008
Completion Date:
December 2012
Related Keywords:
- Hepatocellular Carcinoma
- Carcinoma, Hepatocellular
- Chemoembolization, Therapeutic
- Cytoreductive
- Carcinoma
- Carcinoma, Hepatocellular
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