Clinical trial NCT00820053: A Trial of Adjuvant Transarterial Chemoembolization (TACE) for Preventing Tumor Recurrence After Liver Resection
Official title: Eastern Hepatobilliary Surgical Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
adjuvant therapy
TACE
time to recurrence
overall survival
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2009-01-09
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to analyze the therapeutic effect of adjuvant TACE after resection.Patients receiving curative resection (R0) were randomized to postoperative TACE group and no TACE group. The time to recurrence ,the overall survival as well as the incidence of complications after therapy was observed to confirm the role of adjuvant TACE.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 2010
Secondary outcomes:
measure: Time to recurrence
timeFrame: 2010
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
affiliation: Eastern hepatobilliary surgery hospital
name: Shen feng, MD
role: STUDY_CHAIR
References: