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

NCT00820053 | Completed Phase 2 DMC

• 1 other identifier: EHBH-RCT-2008-014-2
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; adjuvant therapy; TACE; time to recurrence; overall survival

Outcome Measures

Primary Outcomes (1)

• Overall survival

  2010

Secondary Outcomes (1)

• Time to recurrence

  2010

Study Arms (2)

no adjuvant TACE

NO INTERVENTION

controll group with patients who don't receive any adjuvant therapy after liver resection, to compare with the treatment group with patients who receive adjuvant TACE after liver resection

adjuvant TACE

EXPERIMENTAL

patients who adjuvant TACE after liver resection

Drug: epirubicin and lipiodol

Interventions

epirubicin and lipiodol DRUG

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

Also known as: transarterial chemoembolization

adjuvant TACE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients \> 18 years and \<=70 years of age.
• Patients with HCC who received curative liver resection (R0).
• 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 .
• Karnofsky Performance Score performance over 60 .
• Patients who can understand this trial and have signed information consent

You may not qualify if:

• Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction,which may affect the treatment of liver cancer.
• Patients with other diseases which may affect the treatment mentioned here.
• Patients with 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.
• Patients would not sign the consent to the trial.

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Epirubicin; Ethiodized Oil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Shen feng, MD

  Eastern hepatobilliary surgery hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 9, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

CN (1)