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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


Phase 1
18 Years
70 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

2010

Safety Issue:

No

Principal Investigator

Feng Shen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Eastern hepatobilliary surgery hospital

Authority:

China: Ministry of Health

Study ID:

EHBH-RCT-2008-001

NCT ID:

NCT00826384

Start Date:

October 2008

Completion Date:

December 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • transcatheter arterial chemoembolization
  • overall survival
  • Carcinoma
  • Carcinoma, Hepatocellular

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