NCT01393197
Unknown
Not Applicable
Clinical Trial of Transcatheter Arterial Chemoembolization (TACE)With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas
Tianjin Medical University Cancer Institute and Hospital1 site in 1 country2,480 target enrollmentMarch 2011
ConditionsCarcinoma, Hepatocellular
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carcinoma, Hepatocellular
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Enrollment
- 2480
- Locations
- 1
- Primary Endpoint
- Time to progression
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the effects of Transcatheter Arterial Chemoembolization (TACE) with KMG microsphere in treating HCC. And to determine which one is better,KMG microsphere or lipiodol?
Detailed Description
The most important part of effect in TACE is embolization .But there is no clinical trials on which one is better,KMG microsphere or lipiodol? what effect did chemo play in the TACE treating HCC? Which one is better,routine dose or low dose? Experts in USA and Japan had their own researches and standpoints.We think it is important to push a clinical trail to answer these problem.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Hepatocellular Carinomas with diagnosis of pathology or cytology or consistent with China 2001 guideline of Clinical Diagnosis Hepatocellular Carinomas clinical stage（The Barcelona Liver Clinic staging system,BCLC B and C)，or can not receive surgical intervention
- •liver function:Child-Pugh A、B
- •PST 0-1（Eastern Cooperative Oncology Group Performance Score ,ECOG）
- •Lifespan≥6 months
- •First time to receive treatment
- •Can accept the follow up
- •informed consent was gotten
- •the number of lesion ≤ 5
Exclusion Criteria
- •pregnant or lactation woman
- •emotional disturbance
- •serious heart ,lung disfunction or serious diabetes mellitus
- •serious reactiveness infections;（exp:type B or C hepatitis）
- •liver function :Child-Pugh Score C
- •thrombocyte\<6×109/L
- •diffuse HCC
- •widespread metastasis
- •serious atherosclerosis
- •acquired immunodeficiency syndrome;AIDS
Outcomes
Primary Outcomes
Time to progression
Time Frame: 3 years
Time to progression
Secondary Outcomes
- total survival(3 years)
- remission rate(3 years)
Study Sites (1)
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