Carcinoma, Hepatocellular
Conditions
Keywords
HCC, TACE
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.
Interventions
Transcatheter Arterial Chemoembolization
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression | 3 years | Time to progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total survival | 3 years | total survival |
| remission rate | 3 years | remission rate |
Countries
China
Contacts
Primary ContactZhi Guo, MD
Backup ContactHaipeng Yu, MD
Outcome results
None listed