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

Carcinoma, Hepatocellular Clinical Trial

— TACE-KMG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01393093
• Other study ID #: TMU-CIH-IR-002
• Status: Recruiting
• Phase: N/A
• First received: July 11, 2011
• Last updated: June 9, 2017
• Start date: March 2011
• Est. completion date: December 2018

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
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2840
• Est. completion date: December 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular

Intervention

Procedure:
• Therapeutic Chemoembolization
Transcatheter Arterial Chemoembolization

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer 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
Secondary	total survival	total survival	3 year
Secondary	remission rate	remiision rate	3 years

External Links

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