Eastern Hepatobilliary Surgical Hospital
18 Years
70 Years
Both
Hepatocellular Carcinoma
Trial Information
Eastern Hepatobilliary Surgical Hospital
Although resection of hepatocellular carcinoma is potentially curative, local recurrence is
common with the recurrence rate higher than 50% during 5 years. So to reduce the recurrence
rate of HCC, some interventions had been tried in clinic, including transarterial
chemoembolization (TACE), immunotherapy, and interferon treatment etc. But few of these
adjuvant therapies had been proved effective and their long term efficacy and clinical
application remained further explored.
TACE had been prove to be effective in patients with advanced stage of HCC in randomized
controlled trials and meta-analysis, but the role of adjuvant TACE after liver resection is
controversial. The results getting from different randomized control trials varied
significantly because of the bias of patient selection, different study design，the small
size of sample, different drug used in chemotherapy and lack of proper stratification…,so a
big sample size, well patients selected and well designed randomized controlled trial is
needed to further confirm the role of the postoperative TACE.
Patients with HCC who received curative liver resection (R0) were randomly assigned 1:1 by
the doctors to receive no adjuvant TACE(control group) or TACE(treatment group). All
patients in the treatment group received adjuvant TACE 45 days after liver resection. The
outcomes of patients were evaluated during the 3-years follow up.
Inclusion Criteria:
1. Male or female patients > 18 years and <=70 years of age.
2. Patients with HCC who received curative liver resection (R0).
3. 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.
4. 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 .
5. Karnofsky Performance Score performance over 60 .
6. Patients who can understand this trial and have signed information consent
Exclusion Criteria:
1. Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction,which may
affect the treatment of liver cancer.
2. Patients with other diseases which may affect the treatment mentioned here.
3. Patients with medical history of other malignant tumors.
4. Subjects participating in other clinical trials.
5. Extrahepatic metastasis, portal vein or other major vascular involvement. liver
function:Child C.
6. Patients would not sign the consent to the trial.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Overall survival
Outcome Time Frame:
2010
Safety Issue:
No
Principal Investigator
Shen feng, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Eastern hepatobilliary surgery hospital
Authority:
China: Ministry of Health
Study ID:
EHBH-RCT-2008-014-2
NCT ID:
NCT00820053
Start Date:
January 2009
Completion Date:
December 2010
Related Keywords:
- Hepatocellular Carcinoma
- hepatocellular carcinoma
- adjuvant therapy
- TACE
- time to recurrence
- overall survival
- Carcinoma
- Carcinoma, Hepatocellular
Name | Location |
|---|
