Status:
COMPLETED
Cytoreductive Surgery and Transarterial Chemoembolization (TACE) Versus TACE for Hepatocellular Carcinoma
Lead Sponsor:
Eastern Hepatobiliary Surgery Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
NA
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 treatm...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00820157
Start Date
November 1 2008
End Date
December 1 2012
Last Update
August 13 2013
Active Locations (1)
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1
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, China, 200438