Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas (TACE-KMG)

Not Applicable

• Conditions: Carcinoma, Hepatocellular
• Interventions: Other: Therapeutic Chemoembolization

• Registration Number: NCT01393197
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Study Timeline

• Status Verified: 2010-11
• Study Start: 2011-03
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-12
• Study First Posted: 2011-07-13
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18
• Primary Completion: 2016-11
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2480

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
TACE-KMG(without chemo)	Therapeutic Chemoembolization	embolization agent:KMG microsphere( 150-450µm,0.2-2g)
TACE -oil	Therapeutic Chemoembolization	embolization agent:Iodinated Oil or /and gelatin sponge Iodinated Oil （5-30ml）with Epirubicin （30-40mg/m2） or and gelatin sponge
TACE-KMG ( routine dose Chemo)	Therapeutic Chemoembolization	embolization agent:KMG microsphere( 150-450µm,0.2-2g) with routine dose Epirubicin （30-40mg/m2）
TACE-KMG( low dose Chemo )	Therapeutic Chemoembolization	embolization agent:KMG microsphere( 150-450µm,0.2-2g) with low dose Epirubicin （5-10mg/m2）

Primary Outcome Measures

Name	Time	Method
Time to progression	3 years	Time to progression

Secondary Outcome Measures

Name	Time	Method
total survival	3 years	total survival
remission rate	3 years	remission rate

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China