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

Tianjin Medical University

Status: Unknown

Conditions: Carcinoma, Hepatocellular

Treatments: Procedure: Therapeutic Chemoembolization

Study type: Interventional

Funder types: Other

Identifiers

NCT01393093

TMU-CIH-IR-002

Details and patient eligibility

About

The purpose of the study is to evaluate the effects of Transcatheter Arterial Chemoembolization (TACE) with KMG microsphere in treating advance-stage Hepatocellular Carinoma(HCC).

Full description

This is a prospective, multicentre, random, controlled clinical trial of Transcatheter Arterial Chemoembolization (TACE)with KMG Microsphere Treating Advance-stage Hepatocellular Carinomas.

Enrollment: 2,840 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Hepatocellular Carinomas with diagnosis of pathology or cytology or consistent with China 2001 guideline of Clinical Diagnosis Hepatocellular Carinomas
2. clinical stage（The Barcelona Liver Clinic staging system,BCLC B and C)，or can not receive surgical intervention
3. liver function:Child-Pugh A、B
4. PST 0-1（Eastern Cooperative Oncology Group Performance Score ,ECOG）
5. Lifespan≥6 months
6. First time to receive treatment
7. Can accept the follow up
8. informed consent was gotten
9. the number of lesion ≤ 5

Exclusion criteria

1. pregnant or lactation woman
2. emotional disturbance
3. serious heart ,lung disfunction or serious diabetes mellitus
4. serious reactiveness infections;（exp:type B or C hepatitis）
5. liver function :Child-Pugh Score C
6. thrombocyte<6×109/L
7. diffuse HCC
8. widespread metastasis
9. serious atherosclerosis
10. acquired immunodeficiency syndrome;AIDS
11. thrombosis or thrombosis event in 6 months
12. renal inadequacy who need hemodialysis or peritoneal dialysis
13. with other tumors except basal cell carcinoma and carcinoma in situ of cervix
14. 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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2,840 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:

Procedure: 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:

Procedure: 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:

Procedure: Therapeutic Chemoembolization

TACE-KMG(withou chemo)

Experimental group

Description:

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

Treatment:

Procedure: Therapeutic Chemoembolization