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

Tianjin Medical University

Status: Unknown

Conditions: Carcinoma, Hepatocellular

Treatments: Other: Therapeutic Chemoembolization

Study type: Interventional

Funder types: Other

Identifiers

NCT01393197

TMU-CIH-IR-003

Details and patient eligibility

About

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?

Full 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.

Enrollment: 2,480 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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2,480 participants in 4 patient groups

TACE -oil

Active Comparator group

Description:

embolization agent:Iodinated Oil or /and gelatin sponge Iodinated Oil （5-30ml）with Epirubicin （30-40mg/m2） or and gelatin sponge

Treatment:

Other: Therapeutic Chemoembolization

TACE-KMG ( routine dose Chemo)

Experimental group

Description:

embolization agent:KMG microsphere( 150-450µm,0.2-2g) with routine dose Epirubicin （30-40mg/m2）

Treatment:

Other: Therapeutic Chemoembolization

TACE-KMG( low dose Chemo )

Experimental group

Description:

embolization agent:KMG microsphere( 150-450µm,0.2-2g) with low dose Epirubicin （5-10mg/m2）

Treatment:

Other: Therapeutic Chemoembolization

TACE-KMG(without chemo)

Experimental group

Description:

embolization agent:KMG microsphere( 150-450µm,0.2-2g)

Treatment:

Other: Therapeutic Chemoembolization