Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas (TACE-KMG)
NCT ID: NCT01393197
Last Updated: 2015-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
2480 participants
INTERVENTIONAL
2011-03-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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TACE -oil
embolization agent:Iodinated Oil or /and gelatin sponge Iodinated Oil （5-30ml）with Epirubicin （30-40mg/m2） or and gelatin sponge
Therapeutic Chemoembolization
Transcatheter Arterial Chemoembolization
TACE-KMG ( routine dose Chemo)
embolization agent:KMG microsphere( 150-450µm,0.2-2g) with routine dose Epirubicin （30-40mg/m2）
Therapeutic Chemoembolization
Transcatheter Arterial Chemoembolization
TACE-KMG( low dose Chemo )
embolization agent:KMG microsphere( 150-450µm,0.2-2g) with low dose Epirubicin （5-10mg/m2）
Therapeutic Chemoembolization
Transcatheter Arterial Chemoembolization
TACE-KMG(without chemo)
embolization agent:KMG microsphere( 150-450µm,0.2-2g)
Therapeutic Chemoembolization
Transcatheter Arterial Chemoembolization
Interventions
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Therapeutic Chemoembolization
Transcatheter Arterial Chemoembolization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Principal Investigators
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Zhi Guo, MD
Role: STUDY_CHAIR
Tianjin Medical University Cancer Institute and Hospital
Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhi Guo, MD
Role: primary
Haipeng Yu, MD
Role: backup
Related Links
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Related Info
Other Identifiers
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TMU-CIH-IR-003
Identifier Type: -
Identifier Source: org_study_id