Clinical Trial of Transcatheter Arterial Chemoembolization (TACE)With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas
18 Years
75 Years
Both
Carcinoma, Hepatocellular
Trial Information
Clinical Trial of Transcatheter Arterial Chemoembolization (TACE)With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas
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.
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
- thrombosis or thrombosis event in 6 months
- renal inadequacy who need hemodialysis or peritoneal dialysis
- with other tumors except basal cell carcinoma and carcinoma in situ of cervix
- serious alimentary tract hemorrhage in 4 weeks
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Time to progression
Outcome Description:
Time to progression
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Zhi Guo, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Tianjin Medical University Cancer Institute and Hospital
Authority:
China: Food and Drug Administration
Study ID:
TMU-CIH-IR-003
NCT ID:
NCT01393197
Start Date:
March 2011
Completion Date:
March 2014
Related Keywords:
- Carcinoma, Hepatocellular
- HCC
- TACE
- Carcinoma
- Carcinoma, Hepatocellular
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