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