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

Carcinoma, Hepatocellular Clinical Trial

— TACE-KMG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01393197
• Other study ID #: TMU-CIH-IR-003
• Status: Recruiting
• Phase: N/A
• First received: July 11, 2011
• Last updated: December 17, 2015
• Start date: March 2011
• Est. completion date: December 2016

Study information

• Verified date: November 2010
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Zhi Guo, MD
• Phone: 13920076145
• Email: cjr.guozhi[@]vip.163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2480
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular

Intervention

Other:
• Therapeutic Chemoembolization
Transcatheter Arterial Chemoembolization

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression	Time to progression	3 years	No
Secondary	total survival	total survival	3 years	No
Secondary	remission rate	remission rate	3 years	No

External Links

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