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

Not Applicable

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

• Registration Number: NCT01393093
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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).

Detailed Description

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

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
• Primary Completion: 2016-11
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2840

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
TACE-KMG(withou 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
remission rate	3 years	remiision rate
total survival	3 year	total survival

Trial Locations

Locations (1)

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