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OpenTrials
Completed

NCT Number: NCT00826384

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

balloon catheter

Procedure

transcatheter arterial chemoembolization therapy with balloon catheter

Primary outcomes

  1. Overall survival

    Time frame: 2010

Sponsors and collaborators

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jan 22, 2009
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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