Transarterial Chemoembolization (TACE) Therapy of Hepatocellular Carcinoma (HCC) With Blocking Tumor Blood Temporarily and Enhancing Perfusion

This study is ongoing, but not recruiting participants.

First Received: January 21, 2009 No Changes Posted

Sponsored by:	Eastern Hepatobiliary Surgery Hospital
Information provided by:	Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:	NCT00826384

Purpose

According to radiology imaging, the patients of HCC are divided into two groups(hypovascular tumor group and moderately vascular tumor group). Every group is divided into TACE therapy with balloon catheter subgroup and regular TACE therapy subgroup. Patients take the TACE therapy each 45 days, and have MRI diffusion examine or CT one week before next therapy. All objects are observed until the end event happening or in the group for 6 months.

Condition	Intervention	Phase
Hepatocellular Carcinoma	Procedure: balloon catheter	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 1,Single-Blind, Randomized, Controlled Study to Evaluate the Safety and Effectivity of TACE Therapy of HCC(Hepatocellular Carcinoma) With Blocking Tumor Blood Temporarily and Enhancing Perfu

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

U.S. FDA Resources

Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:

Overall survival [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment:	352
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

transcatheter arterial chemoembolization therapy with balloon catheter

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

sign the written informed consent form provided.
diagnosed clinically as HCC,need to take TACE.

Exclusion Criteria:

have had an allergic reaction following iodine.
have been in any TACE or radiotherapy or biotherapy within 30 days before the study.
HCC of diffuse type,failure of hepatic function, chronic illness or disease including failure of heart function, uncontrolled high blood pressure, heart disorders, serious infection, uncontrolled diabetes mellitus.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826384

Locations

China
Eastern hepatobilliary surgery hospital
shanghai, China, 200438

Sponsors and Collaborators

Eastern Hepatobiliary Surgery Hospital

Investigators

Study Chair:

Feng Shen, MD

Eastern hepatobilliary surgery hospital

More Information

No publications provided

Responsible Party:	Eastern Hepatobiliary Surgery Hospital ( ShenFeng )
Study ID Numbers:	EHBH-RCT-2008-001
Study First Received:	January 21, 2009
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00826384 History of Changes
Health Authority:	China: Ministry of Health; United States: Institutional Review Board

Keywords provided by Eastern Hepatobiliary Surgery Hospital:

hepatocellular carcinoma
transcatheter arterial chemoembolization
overall survival

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular

Gastrointestinal Neoplasms
Hepatocellular Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Liver Neoplasms
Liver Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Neoplasms by Histologic Type
Carcinoma, Hepatocellular
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 11, 2009