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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01393093

Acronym

TACE-KMG

Enrollment

2840

Registered

2011-07-13

Start date

2011-03-31

Completion date

2018-12-31

Last updated

2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Hepatocellular

Keywords

HCC, TACE

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.

Interventions

PROCEDURETherapeutic Chemoembolization

Transcatheter Arterial Chemoembolization

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Time to progression	3 years	Time to progression

Secondary

Measure	Time frame	Description
total survival	3 year	total survival
remission rate	3 years	remiision rate

Countries

China

Contacts

Primary ContactZhi Guo, MD

cjr.guozhi@vip.163.com13920076145

Backup ContactHaipeng Yu, MD

jieruke@yahoo.com.cn13352070835

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026