Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas (TACE-KMG) (TACE-KMG)
December 17, 2015 updated by: Tianjin Medical University Cancer Institute and Hospital
Clinical Trial of Transcatheter Arterial Chemoembolization (TACE)With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas
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?
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
2480
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300060
- Recruiting
- Tianjin Medical University Cancer Institute and Hospital
-
Contact:
- Haipeng Yu, MD
- Phone Number: 13352070835
- Email: jieruke@yahoo.com.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: TACE -oil
embolization agent:Iodinated Oil or /and gelatin sponge Iodinated Oil （5-30ml）with Epirubicin （30-40mg/m2） or and gelatin sponge
|
Transcatheter Arterial Chemoembolization
Other Names:
|
|
Experimental: TACE-KMG ( routine dose Chemo)
embolization agent:KMG microsphere( 150-450µm,0.2-2g)
with routine dose Epirubicin （30-40mg/m2）
|
Transcatheter Arterial Chemoembolization
Other Names:
|
|
Experimental: TACE-KMG( low dose Chemo )
embolization agent:KMG microsphere( 150-450µm,0.2-2g)
with low dose Epirubicin （5-10mg/m2）
|
Transcatheter Arterial Chemoembolization
Other Names:
|
|
Experimental: TACE-KMG(without chemo)
embolization agent:KMG microsphere( 150-450µm,0.2-2g)
|
Transcatheter Arterial Chemoembolization
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to progression
Time Frame: 3 years
|
Time to progression
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
total survival
Time Frame: 3 years
|
total survival
|
3 years
|
|
remission rate
Time Frame: 3 years
|
remission rate
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Zhi Guo, MD, Tianjin Medical University Cancer Institute and Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Anticipated)
November 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
July 11, 2011
First Submitted That Met QC Criteria
July 12, 2011
First Posted (Estimate)
July 13, 2011
Study Record Updates
Last Update Posted (Estimate)
December 18, 2015
Last Update Submitted That Met QC Criteria
December 17, 2015
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMU-CIH-IR-003
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