A Trial of Adjuvant Transarterial Chemoembolization (TACE) for Preventing Tumor Recurrence After Liver Resection

Hepatocellular Carcinoma Clinical Trial

Official title:

Eastern Hepatobilliary Surgical Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820053
• Other study ID #: EHBH-RCT-2008-014-2
• Status: Completed
• Phase: Phase 2
• First received: January 7, 2009
• Last updated: March 30, 2016
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of HealthUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• epirubicin and lipiodol
using the technology of Seldinger,The drugs (30 mg epirubicin mixed with 5 ml lipiodol) are given via hepatica propria artery.

Locations

Country	Name	City	State
China	Eastern hepatobilliary surgery hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		2010	No
Secondary	Time to recurrence		2010	No